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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: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 1000143502
DUNS Number: —

Catalogue (3843)

Page 69 of 77

Device	Model / Reference	Registries	Class	Status
BKS TriMax	165-3601	FDA UDI	Class II	Active
Ibis	752-4550-21A	FDA UDI	Class II	Active
BKS® Uni	763-6102	FDA UDI	Class II	Active
Ovation Hip Stem	101-1008	FDA UDI	Class II	Active
BKS® Uni	763-2102	FDA UDI	Class II	Active
Pagoda	158-3050-01A	FDA UDI	Class II	Active
BKS E-Vitalize	166-6607	FDA UDI	Class II	Active
Ibis	158-1090-03A	FDA UDI	Class II	Active
Balanced Knee System Revision	567-5206A	FDA UDI	Class II	Active
Balanced Knee System	161-2202	FDA UDI	Class II	Active
Balanced Knee Revision System	561-0710	FDA UDI	Class II	Active
Ibis	158-1110-03A	FDA UDI	Class II	Active
BKS® Uni	763-4092	FDA UDI	Class II	Active
Legend	173-3654	FDA UDI	Class II	Active
Trivicta	513-1207	FDA UDI	Class II	Active
BKS® Uni	763-3071	FDA UDI	Class II	Active
Alpine	700-0311	FDA UDI	Class II	Active
Balanced Knee System	161-3201A	FDA UDI	Class II	Active
Balance Knee Revision System	566-1411	FDA UDI	Class II	Active
Ovation Tribute Hip Stem	101-1306	FDA UDI	Class II	Active
Vusion CS Plus	159-1405-00	FDA UDI	Class II	Unknown
Ibis	158-0150-03	FDA UDI	Class II	Unknown
Legend	173-3246	FDA UDI	Class II	Active
Vusion OS	551-7412A	FDA UDI	Class II	Active
Legend	175-3650	FDA UDI	Class II	Active
BKS® Uni	763-8061	FDA UDI	Class II	Active
Vusion OS	551-7309A	FDA UDI	Class II	Active
Trivicta	513-1205	FDA UDI	Class II	Active
Vusion TS	551-5013A	FDA UDI	Class II	Active
Legend	172-4064	FDA UDI	Class II	Active
Escalade Acetabular System	170-4058	FDA UDI	Class II	Active
Vusion OS	551-6116	FDA UDI	Class II	Unknown
Balanced Knee System	163-2114	FDA UDI	Class II	Active
Balanced Knee System Revision	568-1104A	FDA UDI	Class II	Active
Balance Knee Revision System	563-1212	FDA UDI	Class II	Active
Balanced Knee System	163-1409	FDA UDI	Class II	Active
Legend	174-3656	FDA UDI	Class II	Active
Pagoda	752-4525-12	FDA UDI	Class II	Unknown
Balanced Knee System Revision	568-2102A	FDA UDI	Class II	Active
Balanced Knee Revision System	563-2514	FDA UDI	Class II	Active
Pagoda	752-4530-12A	FDA UDI	Class II	Active
Balanced Knee System	163-3613	FDA UDI	Class II	Active
Balance Knee Revision System	563-1320	FDA UDI	Class II	Active
Ibis	752-8530-21	FDA UDI	Class II	Unknown
Vusion OS	551-6411	FDA UDI	Class II	Unknown
Pagoda	158-0030A	FDA UDI	Class II	Active
Balanced Knee Revision System	563-2108	FDA UDI	Class II	Active
Entrada Hip Stem	510-1218	FDA UDI	Class II	Active
Entrada Hip Stem	510-0009	FDA UDI	Class II	Active
Escalade Acetabular System	170-0054	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.