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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 70 of 77

Device	Model / Reference	Registries	Class	Status
Balanced Knee System	163-1210	FDA UDI	Class II	Active
Balanced Knee System	161-1302A	FDA UDI	Class II	Active
Balanced Knee System	163-5412	FDA UDI	Class II	Active
Ibis	752-7530-41A	FDA UDI	Class II	Active
Integrated Spine System	158-0080	FDA UDI	Class II	Unknown
Pagoda	158-0120B	FDA UDI	Class II	Active
Vusion OS	551-7409A	FDA UDI	Class II	Active
Balance Knee Revision System	562-3005	FDA UDI	Class II	Active
BKS TriMax PS Plus	166-8113	FDA UDI	Class II	Active
BKS E-Vitalize	166-6508	FDA UDI	Class II	Active
Balanced Knee System	163-1214	FDA UDI	Class II	Active
Balance Knee Revision System	567-5101	FDA UDI	Class II	Active
Balanced Knee System Revision	568-1304A	FDA UDI	Class II	Active
Pagoda	158-3050A	FDA UDI	Class II	Active
Integrated Spine System	158-6545-01	FDA UDI	Class II	Unknown
Legend Acetabular Shell	170-0452/A	FDA UDI	Class II	Active
Pagoda	752-5525-11A	FDA UDI	Class II	Active
Balanced Knee System	163-3508	FDA UDI	Class II	Active
Pisces Spinal System	753-7535-10A	FDA UDI	Class II	Active
Balanced Knee Revision System	567-6107	FDA UDI	Class II	Active
Balanced Knee System Revision	568-2508A	FDA UDI	Class II	Active
Legend	173-4060	FDA UDI	Class II	Active
Pagoda	158-3080B	FDA UDI	Class II	Active
BKS® Uni	761-1501	FDA UDI	Class II	Active
Integrated Spine System	158-0075	FDA UDI	Class II	Unknown
Ovation	101-1405	FDA UDI	Class II	Active
Balanced Knee Revision System	569-1315	FDA UDI	Class II	Active
Pagoda	752-5535-12A	FDA UDI	Class II	Active
Vusion OS	551-6208	FDA UDI	Class II	Unknown
Balanced Knee System	162-5400	FDA UDI	Class II	Active
Vusion TS	551-5218	FDA UDI	Class II	Unknown
Vusion CS Plus	159-1210-07A	FDA UDI	Class II	Active
Ibis	752-7530-26A	FDA UDI	Class II	Active
Balanced Knee System	163-5612	FDA UDI	Class II	Active
Pagoda	752-8550-11	FDA UDI	Class II	Unknown
Legend	174-2862	FDA UDI	Class II	Active
Balanced Knee Revision System	563-2508	FDA UDI	Class II	Active
Vusion OS	551-6311	FDA UDI	Class II	Unknown
BKS® Uni	762-1200A	FDA UDI	Class II	Active
Balance Knee Revision System	566-1111	FDA UDI	Class II	Active
Vusion PS	551-3108	FDA UDI	Class II	Unknown
Vusion PS	551-5316	FDA UDI	Class II	Unknown
Pagoda	752-6535-11	FDA UDI	Class II	Unknown
Pisces Spinal System	753-6560-10A	FDA UDI	Class II	Active
Balanced Knee System	162-1700A	FDA UDI	Class II	Active
Balanced Knee System	163-2313	FDA UDI	Class II	Active
Ovation Tribute Hip Stem	101-0396	FDA UDI	Class II	Active
Trivicta	513-1009	FDA UDI	Class II	Active
Vusion CS Plus	159-1408-07A	FDA UDI	Class II	Active
Balanced Knee System	163-1611	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.