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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 68 of 77

Device	Model / Reference	Registries	Class	Status
Envision	154-5235	FDA UDI	Class II	Unknown
Vusion CS Plus	159-1407-00A	FDA UDI	Class II	Active
Balance Knee Revision System	567-7101	FDA UDI	Class II	Active
Vusion TS	551-5016	FDA UDI	Class II	Unknown
BKS E-Vitalize	166-7214	FDA UDI	Class II	Active
Pagoda	752-4540-12A	FDA UDI	Class II	Active
Balanced Knee Revision System	563-2120	FDA UDI	Class II	Active
Pagoda	752-5535-31	FDA UDI	Class II	Unknown
Biolox Delta	136-4003	FDA UDI	Class II	Active
Vusion CS Plus	159-1605-07A	FDA UDI	Class II	Active
BKS E-Vitalize	166-7409	FDA UDI	Class II	Active
Envision	154-5352	FDA UDI	Class II	Unknown
Balance Knee Revision System	563-1228	FDA UDI	Class II	Active
Pagoda	158-3090-01	FDA UDI	Class II	Unknown
Balanced Knee System	162-1400A	FDA UDI	Class II	Active
Balanced Knee System	163-3712	FDA UDI	Class II	Active
Balanced Knee System Revision	567-5207A	FDA UDI	Class II	Active
Balanced Knee System	161-1301A	FDA UDI	Class II	Active
Vusion OS	551-6215A	FDA UDI	Class II	Active
Ovation Tribute Hip Stem	101-0395	FDA UDI	Class II	Active
Pivot Bipolar	133-2240	FDA UDI	Class II	Active
Tri-plus	138-2860	FDA UDI	Class II	Active
Legend	174-2854	FDA UDI	Class II	Active
Balanced Knee System	163-2609	FDA UDI	Class II	Active
BKS E-Vitalize	166-7120	FDA UDI	Class II	Active
Vusion OS	551-6109A	FDA UDI	Class II	Active
Ibis	752-8545-21	FDA UDI	Class II	Unknown
Legend	173-4056	FDA UDI	Class II	Active
Balanced Knee Revision System	563-2314	FDA UDI	Class II	Active
Envision	154-5232	FDA UDI	Class II	Unknown
Balanced Knee Revision System	563-2316	FDA UDI	Class II	Active
Ibis	752-5550-21	FDA UDI	Class II	Unknown
Alpine Hip System	700-1018	FDA UDI	Class II	Active
Legend	174-3248	FDA UDI	Class II	Active
Entrada Hip Stem	510-0008	FDA UDI	Class II	Active
Pagoda	158-0080-01A	FDA UDI	Class II	Active
Ibis	752-8550-26	FDA UDI	Class II	Unknown
Balanced Knee System Revision	568-1508A	FDA UDI	Class II	Active
Ibis	752-8540-21	FDA UDI	Class II	Unknown
Alpine	700-1210	FDA UDI	Class II	Active
Balanced Knee System Revision	567-5204A	FDA UDI	Class II	Active
Ibis	752-8540-26	FDA UDI	Class II	Unknown
BKS TriMax PS Plus	166-8512	FDA UDI	Class II	Active
Balanced Knee Revision System	563-2614	FDA UDI	Class II	Active
Vusion OS	551-6414	FDA UDI	Class II	Unknown
Vusion OS	551-7109A	FDA UDI	Class II	Active
Encompass Hip Stem	106-0015	FDA UDI	Class II	Active
Pagoda	158-0105B	FDA UDI	Class II	Active
Vusion PS	551-3109	FDA UDI	Class II	Unknown
Balance Knee Revision System	566-1108	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.