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Ortho Development Corp.

Also registered as Ortho Development, Ortho Development Corporation

United Statesfrom the FDA registration address FDA establishment FEI 1000143502

Devices
8,843
Registrations
FDA
FDA recalls
280 ongoing since 2021 (2 open in total)
2 open since before 2021

What Ortho Development Corp. makes

Ortho Development Corp. manufactures orthopedic implants including tibial inserts, acetabular shells, knee and hip prostheses (both uncoated and coated, modular and fixed), spinal bone screws, polymeric spinal interbody fusion cages, and knee arthroplasty wedges. Specific device examples include the Pagoda, Balance Knee Revision System, BKS TriMax PS Plus, Trivicta, Escalade Acetabular System, BKS E-Vitalize, and BKS® Uni.

All listed devices are classified as Class II medical devices and are registered in the FDA’s Unique Device Identification (fda_udi) system. The company is based in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue8,843

Newest first, rows 1-50 of 8,843

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  • 228-0031

    Listed Registry: GUDID Class:I

  • 233-0138

    Listed Registry: GUDID Class:I

  • 233-0139

    Listed Registry: GUDID Class:I

  • 233-0140

    Listed Registry: GUDID Class:I

  • 233-0142

    Listed Registry: GUDID Class:I

  • 233-0141

    Listed Registry: GUDID Class:I

  • 233-0145

    Listed Registry: GUDID Class:I

  • 233-0143

    Listed Registry: GUDID Class:I

  • 233-0144

    Listed Registry: GUDID Class:I

  • 233-0146

    Listed Registry: GUDID Class:I

  • 233-0147

    Listed Registry: GUDID Class:I

  • 233-0148

    Listed Registry: GUDID Class:I

  • 233-0149

    Listed Registry: GUDID Class:I

  • 233-0150

    Listed Registry: GUDID Class:I

  • 233-0151

    Listed Registry: GUDID Class:I

  • 233-0153

    Listed Registry: GUDID Class:I

  • 233-0156

    Listed Registry: GUDID Class:I

  • 233-0154

    Listed Registry: GUDID Class:I

  • 233-0155

    Listed Registry: GUDID Class:I

  • 233-0152

    Listed Registry: GUDID Class:I

  • 233-0157

    Listed Registry: GUDID Class:I

  • 233-0158

    Listed Registry: GUDID Class:I

  • 233-0159

    Listed Registry: GUDID Class:I

  • 233-0160

    Listed Registry: GUDID Class:I

  • 233-0200

    Listed Registry: GUDID Class:I

  • 233-0203

    Listed Registry: GUDID Class:I

  • 233-0206

    Listed Registry: GUDID Class:I

  • 233-0209

    Listed Registry: GUDID Class:I

  • 233-0230

    Listed Registry: GUDID Class:I

  • 233-0260

    Listed Registry: GUDID Class:I

  • 233-0300

    Listed Registry: GUDID Class:I

  • 233-0303

    Listed Registry: GUDID Class:I

  • 233-0306

    Listed Registry: GUDID Class:I

  • 233-0309

    Listed Registry: GUDID Class:I

  • 233-0330

    Listed Registry: GUDID Class:I

  • 233-0360

    Listed Registry: GUDID Class:I

  • 233-0402

    Listed Registry: GUDID Class:I

  • 233-0403

    Listed Registry: GUDID Class:I

  • 265-5101B

    Listed Registry: GUDID Class:I

  • 853-1051

    Listed Registry: GUDID Class:I

  • 265-5102B

    Listed Registry: GUDID Class:I

  • 265-5202B

    Listed Registry: GUDID Class:I

  • 265-5104B

    Listed Registry: GUDID Class:I

  • 265-5201B

    Listed Registry: GUDID Class:I

  • 265-5204B

    Listed Registry: GUDID Class:I

  • 265-5251B

    Listed Registry: GUDID Class:I

  • 265-5252B

    Listed Registry: GUDID Class:I

  • 265-5254B

    Listed Registry: GUDID Class:I

  • 265-5302B

    Listed Registry: GUDID Class:I

  • 265-5301B

    Listed Registry: GUDID Class:I

Rows 1-50 of 8,843

Showing 1-50 of 8,843

Company details

FDA FEI number
1000143502
Address
12187 SOUTH BUSINESS PARK DR., DRAPER, UT, 84020

FDA recalls28

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 28 recalls initiated by ORTHO DEVELOPMENT CORP., the earliest on 2002-12-26 and the most recent on 2019-05-30. By recorded status: 2 ongoing and 26 terminated. The reasons filed fall into these groups: labeling or instructions for use, packaging, mechanical integrity and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Recalls initiated per year

  • 2017 0
  • 2018 0
  • 2019 2
  • 2020 0
  • 2021 0
  • 2022 0
  • 2023 0
  • 2024 0
  • 2025 0
  • 2026 0

26 initiated before 2017

Showing the 10 most recent of 28 recalls.

  • 2019

    • 30 May 2019 Z-1903-2020 Class II Open since 2019 The locking mechanism of the tibial tray exhibited a manufacturing defect in which a uniform ridge was cut along the inner wall of the "T" and "Y" junctions, which may cause resistance when the Tibial Insert was being assembled. Distribution: US: CA, FL, OH, PA, TX, and UT. OUS: Japan. Submission number: K994370
    • 30 May 2019 Z-1904-2020 Class II Open since 2019 The locking mechanism of the tibial tray exhibited a manufacturing defect in which a uniform ridge was cut along the inner wall of the "T" and "Y" junctions, which may cause resistance when the Tibial Insert was being assembled. Distribution: US: CA, FL, OH, PA, TX, and UT. OUS: Japan. Submission number: K994370

  • 2014

    • 11 Jul 2014 Z-2253-2014 Class II Terminated Ortho Development is recalling various Pivot Bipolar Cup, Patella, PS Tibial Insert, UC Tibila Insert, and CK Tibil Insert because the foil pouches did not properly seal, allowing air to seep back into the pouch after sealing which increases the risk that the material properties of the implant would be substantially degraded due to oxidation. Distribution: Worldwide Distribution - US Nationwide and the country of Japan. No military/govt/VA consignees. Submission number: K050966
    • 11 Jul 2014 Z-2254-2014 Class II Terminated Ortho Development is recalling various Pivot Bipolar Cup, Patella, PS Tibial Insert, UC Tibila Insert, and CK Tibil Insert because the foil pouches did not properly seal, allowing air to seep back into the pouch after sealing which increases the risk that the material properties of the implant would be substantially degraded due to oxidation. Distribution: Worldwide Distribution - US Nationwide and the country of Japan. No military/govt/VA consignees. Submission number: K994370
    • 11 Jul 2014 Z-2255-2014 Class II Terminated Ortho Development is recalling various Pivot Bipolar Cup, Patella, PS Tibial Insert, UC Tibila Insert, and CK Tibil Insert because the foil pouches did not properly seal, allowing air to seep back into the pouch after sealing which increases the risk that the material properties of the implant would be substantially degraded due to oxidation. Distribution: Worldwide Distribution - US Nationwide and the country of Japan. No military/govt/VA consignees. Submission number: K994370
    • 11 Jul 2014 Z-2256-2014 Class II Terminated Ortho Development is recalling various Pivot Bipolar Cup, Patella, PS Tibial Insert, UC Tibila Insert, and CK Tibil Insert because the foil pouches did not properly seal, allowing air to seep back into the pouch after sealing which increases the risk that the material properties of the implant would be substantially degraded due to oxidation. Distribution: Worldwide Distribution - US Nationwide and the country of Japan. No military/govt/VA consignees. Submission number: K090705
    • 11 Jul 2014 Z-2257-2014 Class II Terminated Ortho Development is recalling various Pivot Bipolar Cup, Patella, PS Tibial Insert, UC Tibila Insert, and CK Tibil Insert because the foil pouches did not properly seal, allowing air to seep back into the pouch after sealing which increases the risk that the material properties of the implant would be substantially degraded due to oxidation. Distribution: Worldwide Distribution - US Nationwide and the country of Japan. No military/govt/VA consignees. Submission number: K060569
    • 1 Apr 2014 Z-1610-2014 Class II Terminated A femoral component containing pegs was found in a box for the pegless version. Distribution: US Nationwide Distribution in the states of NV, and AZ. Submission number: K994370

  • 2011

    • 19 Dec 2011 Z-0740-2012 Unclassified (pre-2012) Terminated Tip of hex-head screwdriver may break off during use in hip replacement procedure. Distribution: Nationwide Distribution-including the states of AZ, CA, FL, MI, OR, TX, and UT. Submission number: K103384
    • 10 May 2011 Z-2602-2011 Unclassified (pre-2012) Terminated Tests on PVC packaging material resulted in alert levels for cytotoxicity. Distribution: Nationwide Distribution - USA including CA, FL, and TX. Submission number: K053293
Show the 25 most recent of 28 recalls

  • 2011

    • 10 May 2011 Z-2603-2011 Unclassified (pre-2012) Terminated Tests on PVC packaging material resulted in alert levels for cytotoxicity. Distribution: Nationwide Distribution - USA including CA, FL, and TX. Submission number: K053293
    • 11 Jan 2011 Z-1670-2011 Unclassified (pre-2012) Terminated Component of total hip arthroplasty may break during surgical procedure. Distribution: Nationwide Distribution including AZ, CA, CO, FL, MI, NV, OR, and UT. Submission number: K062775
    • 11 Jan 2011 Z-1671-2011 Unclassified (pre-2012) Terminated Component of total hip arthroplasty may break during surgical procedure. Distribution: Nationwide Distribution including AZ, CA, CO, FL, MI, NV, OR, and UT. Submission number: K062775
    • 11 Jan 2011 Z-1672-2011 Unclassified (pre-2012) Terminated Component of total hip arthroplasty may break during surgical procedure. Distribution: Nationwide Distribution including AZ, CA, CO, FL, MI, NV, OR, and UT. Submission number: K062775
    • 11 Jan 2011 Z-1673-2011 Unclassified (pre-2012) Terminated Component of total hip arthroplasty may break during surgical procedure. Distribution: Nationwide Distribution including AZ, CA, CO, FL, MI, NV, OR, and UT. Submission number: K062775
    • 7 Jan 2011 Z-1740-2011 Unclassified (pre-2012) Terminated Components of a replacement knee system could be mislabeled. Distribution: Worldwide distribution: USA including states of: AZ, CA, FL, MI, TX, and UT; and country of: Japan. Submission number: K060569
    • 7 Jan 2011 Z-1741-2011 Unclassified (pre-2012) Terminated Components of a replacement knee system could be mislabeled. Distribution: Worldwide distribution: USA including states of: AZ, CA, FL, MI, TX, and UT; and country of: Japan. Submission number: K060569
    • 7 Jan 2011 Z-1742-2011 Unclassified (pre-2012) Terminated Components of a replacement knee system could be mislabeled. Distribution: Worldwide distribution: USA including states of: AZ, CA, FL, MI, TX, and UT; and country of: Japan. Submission number: K060569

  • 2010

    • 28 Jul 2010 Z-0315-2011 Unclassified (pre-2012) Terminated The hip stem did not fit the distal centralizer because the hole was not drilled with the appropriate taper. Distribution: Worldwide Distribution: Japan Submission number: K962448

  • 2009

    • 29 May 2009 Z-1993-2009 Unclassified (pre-2012) Terminated Erroneous lot number on 3 of 28 units of Balanced Knee System. Three units from Lot Number 0055245 were mixed in with the recalled lot (0054891). Distribution: Worldwide -- US (states of FL and TX) and Japan. Submission number: K994370
    • 29 Apr 2009 Z-0086-2010 Unclassified (pre-2012) Terminated A Pivot BiPolar Head, the femoral head in a hip prosthesis, might not move freely after assembly due a stacking up of manufacturing tolerances. Distribution: AZ, CA, FL, MA, MI. No military, government or foreign distribution. Submission number: K050966
    • 19 Mar 2009 Z-1228-2010 Unclassified (pre-2012) Terminated A component of knee prosthesis was assembled incorrectly. Distribution: United States (AZ, FL, OR, TX and UT) and Japan. Submission number: K031201
    • 19 Mar 2009 Z-1229-2010 Unclassified (pre-2012) Terminated A component of knee prosthesis was assembled incorrectly. Distribution: United States (AZ, FL, OR, TX and UT) and Japan. Submission number: K031201

  • 2003

    • 15 Sep 2003 Z-0042-04 Unclassified (pre-2012) Terminated The guide pin which rotationally constrains the tibial punch within the punch guide, may fall out. Distribution: Units were sent to distributors in AZ, CA, FL, MO, OK and TX. Units were also distributed to firm's parent company in…
      Full distribution text Units were sent to distributors in AZ, CA, FL, MO, OK and TX. Units were also distributed to firm's parent company in Japan.

  • 2002

    • 26 Dec 2002 Z-0566-03 Unclassified (pre-2012) Terminated Cleaning agent residue from packaging material was adhering to implantable hip stems. Distribution: TX and Japan Submission number: K953977

Frequently asked questions

How many devices does ORTHO DEVELOPMENT CORP. have in the registry?

The registry currently lists 8843 devices for ORTHO DEVELOPMENT CORP.. Devices recorded under merged duplicate company entries are counted once.

Which registries list ORTHO DEVELOPMENT CORP.'s devices?

Among its 50 most recently registered devices, ORTHO DEVELOPMENT CORP. has devices listed in FDA GUDID (50 devices).

What risk classes do ORTHO DEVELOPMENT CORP.'s devices fall under?

Among its 50 most recently registered devices, the classes recorded for ORTHO DEVELOPMENT CORP.'s devices are Class I. Each device page shows its own class and authorisation.

Are there FDA recall records for ORTHO DEVELOPMENT CORP.?

FDA recall records list 28 recalls initiated by ORTHO DEVELOPMENT CORP., the most recent initiated on 30 May 2019. 2 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from ORTHO DEVELOPMENT CORP. in the registry?

The most recently registered devices listed for ORTHO DEVELOPMENT CORP. include 228-0031, 233-0138, 233-0139 and 233-0140.

Generated automatically from registry data and not verified by a human reviewer.

This is an FDA establishment record. No EUDAMED registration is known for this company.