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ORTHO DEVELOPMENT CORP.

Last updated September 17, 2026

Information

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

Catalogue (3843)

Page 77 of 77

Device	Model / Reference	Registries	Class	Status
Vusion Ts, Ps, And Cs Partial Vertebral Body Replacements	K062666	FDA 510(k)	Class II	Active
The Gecko Spinal System	K200281	FDA 510(k)	Class II	Active
Iss Integrated Spine System	K061524	FDA 510(k)	Class II	Active
Balanced Knee System Modular Revision Knee System	K060569	FDA 510(k)	Class II	Active
Encompass Cemented Hip Stem & 10/12 Cobalt-Chrome Femoral Heads	K050637	FDA 510(k)	Class II	Active
Trivicta® Hip Stem	K251052	FDA 510(k)	Class II	Active
BKS Revision System	K242984	FDA 510(k)	Class II	Active
Entrada™ hip stem	K171249	FDA 510(k)FDA UDI	Class II	Active
Encompass 1017 And 1217 Extended Press-Fit Hip Stems	K053293	FDA 510(k)	Class II	Active
Envision Anterior Cervical Plate System	K020649	FDA 510(k)	Class II	Active
Encompass 10/12 Hip Stem	K132697	FDA 510(k)	Class II	Active
Primaloc Cemented Hip System	K962448	FDA 510(k)	Class II	Active
Ortho Development Balanced Knee Modular Tibial System	K031201	FDA 510(k)	Class II	Active
Ovation Tribute Hip Stem; Ovation Narrow Hip Stem	K133386	FDA 510(k)	Class II	Active
Balanced Knee System TriMax Porous Femoral Components	K253161	FDA 510(k)	Class II	Active
Hemisphere Modular Cup System	K000321	FDA 510(k)	Class II	Active
Bi-Loc Bipolar Cup	K961793	FDA 510(k)	Class II	Active
Alpine Hip Stem; Alpine Ha Hip Stem	K141001	FDA 510(k)	Class II	Active
European Style Taper, Press-Fit Hip Stem	K062775	FDA 510(k)	Class II	Active
Kasm Knee Articulating Spacer Molds	K133449	FDA 510(k)	Class II	Active
Solitude Unipolar Head	K042973	FDA 510(k)	Class II	Active
Pisces Spinal System	K203023	FDA 510(k)FDA UDI	Class II	Active
Balanced Knee Revision System - Offset Junction Box	K180743	FDA 510(k)	Class II	Active
Escalade Acetabular Cup System	K103384	FDA 510(k)	Class II	Active
The Progen™ Trochanteric Nail System	K211086	FDA 510(k)	Class II	Active
Ortho Development Ceramic Femoral Heads	K060577	FDA 510(k)	Class II	Active
Legend All-Poly Cup	K051407	FDA 510(k)	Class II	Active
Escalade Legend Acetabular Shell	K161080	FDA 510(k)	Class II	Active
Hemisphere Acetabular Cup	K960660	FDA 510(k)	Class II	Active
Balanced Knee System TriMax CR Femoral Component and E-Vitalize CR and UC Tibial Inserts	K152169	FDA 510(k)	Class II	Active
Ortho Development Ceramic Femoral Heads With Pres-Fit Stems	K053587	FDA 510(k)	Class II	Active
Balanced Knee System Revision Offset Tibia	K103837	FDA 510(k)	Class II	Active
Pagoda Pedicle Screw System	K131785	FDA 510(k)	Class II	Active
Odc B2 Bipolar Cup	K982389	FDA 510(k)	Class II	Active
Alpine Cemented Hip System	K153216	FDA 510(k)	Class II	Active
Balanced Knee System High Flex Ps	K123457	FDA 510(k)	Class II	Active
Balanced Knee System Uni	K211471	FDA 510(k)	Class II	Active
Headloc Ceramic Head	K970675	FDA 510(k)	Class II	Active
Contour Spinal System	K990986	FDA 510(k)	Class II	Active
Vusion Cs Plus	K122588	FDA 510(k)	Class II	Active
Emf Pal Ii Main Generator And Irrigation Units And Accessories	K062171	FDA 510(k)	Class II	Active
Ovation 10/12 Hip Stem	K131022	FDA 510(k)	Class II	Active
Balanced Knee® System TriMax PS Plus Tibial Insert	K233093	FDA 510(k)	Class II	Active

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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.

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.