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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 17 of 77

Device	Model / Reference	Registries	Class	Status
BKS® Uni	763-7072A	FDA UDI	Class II	Active
Balanced Knee System	163-5112	FDA UDI	Class II	Active
Balance Knee Revision System	562-1400	FDA UDI	Class II	Active
Entrada Hip Stem	510-0017	FDA UDI	Class II	Active
Pagoda	158-0040-01A	FDA UDI	Class II	Active
Pagoda	158-3090A	FDA UDI	Class II	Active
Integrated Spine System	158-1070	FDA UDI	Class II	Unknown
Solitude Unipolar	132-0039	FDA UDI	Class II	Active
Balanced Knee System	163-1208	FDA UDI	Class II	Active
Legend	172-2848	FDA UDI	Class II	Active
Pagoda	158-0045B	FDA UDI	Class II	Active
Vusion OS	551-6114	FDA UDI	Class II	Unknown
Ibis	158-1200-03A	FDA UDI	Class II	Active
Escalade Acetabular System	170-0162	FDA UDI	Class II	Active
BKS® Uni	763-6092A	FDA UDI	Class II	Active
Balanced Knee System	161-1401	FDA UDI	Class II	Active
Balanced Knee Revision System	562-2400A	FDA UDI	Class II	Active
Pagoda	752-4530-11A	FDA UDI	Class II	Active
Balance Knee Revision System	568-1304	FDA UDI	Class II	Active
Pagoda	752-7550-12A	FDA UDI	Class II	Active
Pagoda	158-0045A	FDA UDI	Class II	Active
Vusion OS	551-7515A	FDA UDI	Class II	Active
Ibis	158-1075-03A	FDA UDI	Class II	Active
Balanced Knee System	163-1310	FDA UDI	Class II	Active
Legend	174-3252	FDA UDI	Class II	Active
Pagoda	752-6590-31	FDA UDI	Class II	Unknown
Ibis	158-0085-03A	FDA UDI	Class II	Active
Balanced Knee System	163-2208	FDA UDI	Class II	Active
Balance Knee Revision System	566-1015	FDA UDI	Class II	Active
12/14 CoCr Femoral Head	138-4060	FDA UDI	Class II	Active
Kasm	669-2058	FDA UDI	Class II	Active
Vusion PS	551-5216	FDA UDI	Class II	Unknown
Balanced Knee System	163-5720	FDA UDI	Class II	Active
Ibis	752-8530-41A	FDA UDI	Class II	Active
Balanced Knee System Revision	568-2308A	FDA UDI	Class II	Active
BKS E-Vitalize	166-6309	FDA UDI	Class II	Active
Balanced Knee System	161-1505	FDA UDI	Class II	Active
Balanced Knee System	163-5418	FDA UDI	Class II	Active
Legend	172-2860	FDA UDI	Class II	Active
Pagoda	752-5530-11	FDA UDI	Class II	Unknown
Vusion CS Plus	159-1609-07	FDA UDI	Class II	Unknown
Balanced Knee System	163-3407	FDA UDI	Class II	Active
Vusion OS	551-7610A	FDA UDI	Class II	Active
Balance Knee Revision System	563-1122	FDA UDI	Class II	Active
Ibis Xl	752-9512-57A	FDA UDI	Class II	Active
Vusion OS	551-6214A	FDA UDI	Class II	Active
Ibis	158-0120-03	FDA UDI	Class II	Unknown
BKS E-Vitalize	166-5707	FDA UDI	Class II	Active
Pagoda	752-5540-31A	FDA UDI	Class II	Active
Balance Knee Revision System	566-1911	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.