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ORTHO DEVELOPMENT CORP.

Last updated September 17, 2026

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.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What does Ortho Development Corp. make?

Ortho Development Corp. manufactures orthopedic implants such as 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 examples include the Pagoda, Balance Knee Revision System, BKS TriMax PS Plus, Trivicta, Escalade Acetabular System, BKS E-Vitalize, and BKS® Uni.

Where is Ortho Development Corp. based?

Ortho Development Corp. is based in the United States, as stated in the provided device data under the COUNTRY field.

Which registries list Ortho Development Corp.'s devices?

Ortho Development Corp.'s devices are listed in the FDA’s Unique Device Identification (fda_udi) system, as indicated in the LISTED IN field of the device data.

How are Ortho Development Corp.'s devices classified?

All devices manufactured by Ortho Development Corp. are classified as Class II medical devices, as explicitly stated in the DEVICE CLASSES field of the provided data.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: US
Address: 12187 SOUTH BUSINESS PARK DR., DRAPER, UT, 84020
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 1000143502
DUNS Number: —

Catalogue (3843)

Page 65 of 77

Device	Model / Reference	Registries	Class	Status
Pagoda	752-5550-12	FDA UDI	Class II	Unknown
BKS® Uni	763-1112	FDA UDI	Class II	Active
Balanced Knee Revision System	563-2216	FDA UDI	Class II	Active
Balanced Knee System	163-1311	FDA UDI	Class II	Active
Ibis	752-6530-21A	FDA UDI	Class II	Active
Balanced Knee Revision System	563-2208	FDA UDI	Class II	Active
Pagoda	752-5540-12	FDA UDI	Class II	Unknown
Vusion OS	551-7410	FDA UDI	Class II	Unknown
Vusion TS	551-1013	FDA UDI	Class II	Unknown
Balanced Knee Revision System	566-1322	FDA UDI	Class II	Active
BKS E-Vitalize	166-7714	FDA UDI	Class II	Active
BKS E-Vitalize	166-7213	FDA UDI	Class II	Active
Ovation Hip Stem	101-1009	FDA UDI	Class II	Active
Balanced Knee System	163-2614	FDA UDI	Class II	Active
Balanced Knee System	161-3602A	FDA UDI	Class II	Active
Vusion CS Plus	159-1605-00A	FDA UDI	Class II	Active
Integrated Spine System	158-1050	FDA UDI	Class II	Unknown
BKS TriMax	165-1701	FDA UDI	Class II	Active
BKS® Uni	763-7091	FDA UDI	Class II	Active
Ibis	752-7550-26	FDA UDI	Class II	Unknown
BKS E-Vitalize	166-7514	FDA UDI	Class II	Active
BKS E-Vitalize	166-7316	FDA UDI	Class II	Active
Balanced Knee System	163-1212	FDA UDI	Class II	Active
Balanced Knee Revision System	569-1911	FDA UDI	Class II	Active
Pivot Bipolar	133-2258	FDA UDI	Class II	Active
Balanced Knee System	163-1512	FDA UDI	Class II	Active
Balanced Knee System	161-3202	FDA UDI	Class II	Active
Balanced Knee Revision System	563-2424	FDA UDI	Class II	Active
Vusion PS	551-2111	FDA UDI	Class II	Unknown
Vusion OS	551-6409	FDA UDI	Class II	Unknown
Pisces Spinal System	753-8560-20	FDA UDI	Class II	Active
Entrada Hip Stem	510-1018	FDA UDI	Class II	Active
Balanced Knee System	161-1506A	FDA UDI	Class II	Active
Pagoda	752-4540-31A	FDA UDI	Class II	Active
Ovation	101-0412	FDA UDI	Class II	Active
BKS® Uni	763-3081A	FDA UDI	Class II	Active
Legend	174-2858	FDA UDI	Class II	Active
Vusion OS	551-6416	FDA UDI	Class II	Unknown
Vusion PS	551-5107	FDA UDI	Class II	Unknown
Balanced Knee System	161-4701	FDA UDI	Class II	Active
BKS E-Vitalize	166-7210	FDA UDI	Class II	Active
Balanced Knee System	161-3701A	FDA UDI	Class II	Active
Ovation Tribute Hip Stem	101-0304	FDA UDI	Class II	Active
Balanced Knee Revision System	561-5252	FDA UDI	Class II	Active
Legend Acetabular Shell	170-0562/A	FDA UDI	Class II	Active
Ibis Xl	752-1090-57A	FDA UDI	Class II	Active
BKS E-Vitalize	166-5413	FDA UDI	Class II	Active
Escalade Acetabular System	170-0340	FDA UDI	Class II	Active
Balance Knee Revision System	566-2208	FDA UDI	Class II	Active
Vusion OS	551-7210	FDA UDI	Class II	Unknown

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

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Notified Bodies

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Authorities

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FDA Recalls (28)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

There are 28 recall records for Ortho Development Corp., with the earliest initiated on December 26, 2002, and the most recent on May 30, 2019. The statuses of these recalls include open, classified, and terminated. The reasons given for the recalls include erroneous lot numbers, potential mechanical issues such as restricted movement or breakage of components, incorrect assembly, improper sealing of foil pouches, mislabeling, and manufacturing defects affecting fit or function.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
May 30, 2019	Z-1903-2020	—	open, classified	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.
May 30, 2019	Z-1904-2020	—	open, classified	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.
Jul 11, 2014	Z-2257-2014	—	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.
Jul 11, 2014	Z-2256-2014	—	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.
Jul 11, 2014	Z-2255-2014	—	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.
Jul 11, 2014	Z-2253-2014	—	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.
Jul 11, 2014	Z-2254-2014	—	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.
Apr 1, 2014	Z-1610-2014	—	terminated	A femoral component containing pegs was found in a box for the pegless version.
Dec 19, 2011	Z-0740-2012	—	terminated	Tip of hex-head screwdriver may break off during use in hip replacement procedure.
May 10, 2011	Z-2602-2011	—	terminated	Tests on PVC packaging material resulted in alert levels for cytotoxicity.
May 10, 2011	Z-2603-2011	—	terminated	Tests on PVC packaging material resulted in alert levels for cytotoxicity.
Jan 11, 2011	Z-1673-2011	—	terminated	Component of total hip arthroplasty may break during surgical procedure.
Jan 11, 2011	Z-1670-2011	—	terminated	Component of total hip arthroplasty may break during surgical procedure.
Jan 11, 2011	Z-1671-2011	—	terminated	Component of total hip arthroplasty may break during surgical procedure.
Jan 11, 2011	Z-1672-2011	—	terminated	Component of total hip arthroplasty may break during surgical procedure.
Jan 7, 2011	Z-1740-2011	—	terminated	Components of a replacement knee system could be mislabeled.
Jan 7, 2011	Z-1741-2011	—	terminated	Components of a replacement knee system could be mislabeled.
Jan 7, 2011	Z-1742-2011	—	terminated	Components of a replacement knee system could be mislabeled.
Jul 28, 2010	Z-0315-2011	—	terminated	The hip stem did not fit the distal centralizer because the hole was not drilled with the appropriate taper.
May 29, 2009	Z-1993-2009	—	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).
Apr 29, 2009	Z-0086-2010	—	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.
Mar 19, 2009	Z-1229-2010	—	terminated	A component of knee prosthesis was assembled incorrectly.
Mar 19, 2009	Z-1228-2010	—	terminated	A component of knee prosthesis was assembled incorrectly.
Sep 15, 2003	Z-0042-04	—	terminated	The guide pin which rotationally constrains the tibial punch within the punch guide, may fall out.
Dec 26, 2002	Z-0567-03	—	terminated	Cleaning agent residue from packaging material was adhering to implantable hip stems.
Dec 26, 2002	Z-0568-03	—	terminated	Cleaning agent residue from packaging material was adhering to implantable hip stems.
Dec 26, 2002	Z-0566-03	—	terminated	Cleaning agent residue from packaging material was adhering to implantable hip stems.
Dec 26, 2002	Z-0569-03	—	terminated	Cleaning agent residue from packaging material was adhering to implantable hip stems.