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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 29 of 77

Device	Model / Reference	Registries	Class	Status
Alpine	700-1214	FDA UDI	Class II	Active
Vusion CS Plus	159-1405-00A	FDA UDI	Class II	Active
Pagoda	158-3085B	FDA UDI	Class II	Active
Balanced Knee System	163-1211	FDA UDI	Class II	Active
Vusion CS Plus	159-1205-00A	FDA UDI	Class II	Active
Legend	173-3664	FDA UDI	Class II	Active
Ibis	158-1120-03A	FDA UDI	Class II	Active
Pisces Spinal System	753-4530-10A	FDA UDI	Class II	Active
Envision	154-5485	FDA UDI	Class II	Unknown
Balanced Knee System Revision	567-5104A	FDA UDI	Class II	Active
BKS® Uni	763-2072	FDA UDI	Class II	Active
Legend	174-3258	FDA UDI	Class II	Active
Legend Acetabular Shell	170-0548/A	FDA UDI	Class II	Active
Ibis	158-1050-03	FDA UDI	Class II	Unknown
Legend	174-4060	FDA UDI	Class II	Active
Entrada Hip Stem	510-0214	FDA UDI	Class II	Active
BKS TriMax	165-3701	FDA UDI	Class II	Active
Ibis	158-1030-03A	FDA UDI	Class II	Active
Vusion TS	551-1012	FDA UDI	Class II	Unknown
Pagoda	158-0105-01	FDA UDI	Class II	Unknown
Ibis	752-5525-41	FDA UDI	Class II	Unknown
Vusion OS	551-7214A	FDA UDI	Class II	Active
Balance Knee Revision System	562-2200	FDA UDI	Class II	Active
Vusion OS	551-6313A	FDA UDI	Class II	Active
Entrada Hip Stem	510-1013	FDA UDI	Class II	Active
Ibis Xl	752-8585-57A	FDA UDI	Class II	Active
Vusion PS	551-5312	FDA UDI	Class II	Unknown
Ibis	158-0120-03A	FDA UDI	Class II	Active
Escalade Acetabular System	170-0046	FDA UDI	Class II	Active
Ovation Tribute Hip Stem	101-0385	FDA UDI	Class II	Active
Ovation Tribute Hip Stem	101-1396	FDA UDI	Class II	Active
Balanced Knee System	162-5700	FDA UDI	Class II	Active
Vusion TS	551-5210A	FDA UDI	Class II	Active
Balanced Knee System	163-1708	FDA UDI	Class II	Active
BKS TriMax PS Plus	166-8310	FDA UDI	Class II	Active
Balanced Knee System	163-1411	FDA UDI	Class II	Active
Balanced Knee Revision System	563-2716	FDA UDI	Class II	Active
Ibis	752-6550-21	FDA UDI	Class II	Unknown
Balanced Knee System	161-3302A	FDA UDI	Class II	Active
Ibis	752-6555-26A	FDA UDI	Class II	Active
Balance Knee Revision System	563-1424	FDA UDI	Class II	Active
Balance Knee Revision System	567-5202	FDA UDI	Class II	Active
Vusion PS	551-5307	FDA UDI	Class II	Unknown
Balance Knee Revision System	561-1102	FDA UDI	Class II	Active
Legend Acetabular Shell	170-0544/A	FDA UDI	Class II	Active
Integrated Spine System	158-0150	FDA UDI	Class II	Unknown
Encompass Hip Stem	106-0613	FDA UDI	Class II	Active
Balanced Knee System	161-1201A	FDA UDI	Class II	Active
Pagoda	752-6530-31	FDA UDI	Class II	Unknown
Balanced Knee System	163-2613	FDA UDI	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.