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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 75 of 77

Device	Model / Reference	Registries	Class	Status
Vusion OS	551-6709	FDA UDI	Class II	Unknown
Vusion PS	551-5207	FDA UDI	Class II	Unknown
Vusion TS	551-5011A	FDA UDI	Class II	Active
Balanced Knee System	163-2412	FDA UDI	Class II	Active
BKS® Uni	761-1302	FDA UDI	Class II	Active
BKS TriMax PS Plus	166-8609	FDA UDI	Class II	Active
BKS TriMax PS Plus	166-8410	FDA UDI	Class II	Active
BKS® Uni	763-8102A	FDA UDI	Class II	Active
BKS® Uni	763-2111A	FDA UDI	Class II	Active
BKS® Uni	763-5111	FDA UDI	Class II	Active
BKS® Uni	762-5100A	FDA UDI	Class II	Active
BKS® Uni	763-1061A	FDA UDI	Class II	Active
BKS TriMax PS Plus	166-8216	FDA UDI	Class II	Active
BKS® Uni	763-7081A	FDA UDI	Class II	Active
BKS TriMax PS Plus	166-8108	FDA UDI	Class II	Active
Biolox Delta	136-3604	FDA UDI	Class II	Active
Biolox Delta	136-2803	FDA UDI	Class II	Active
BKS® Uni	763-3111	FDA UDI	Class II	Active
BKS TriMax PS Plus	166-8220	FDA UDI	Class II	Active
BKS TriMax PS Plus	166-8718	FDA UDI	Class II	Active
BKS E-Vitalize	166-5720	FDA UDI	Class II	Active
BKS® Uni	763-5102	FDA UDI	Class II	Active
BKS® Uni	763-6082A	FDA UDI	Class II	Active
BKS® Uni	763-2082A	FDA UDI	Class II	Active
BKS E-Vitalize	166-5508	FDA UDI	Class II	Active
BKS® Uni	763-2091A	FDA UDI	Class II	Active
BKS E-Vitalize	166-7220	FDA UDI	Class II	Active
BKS® Uni	763-7062	FDA UDI	Class II	Active
BKS® Uni	763-8092A	FDA UDI	Class II	Active
BKS® Uni	763-5072	FDA UDI	Class II	Active
BKS® Uni	763-2062	FDA UDI	Class II	Active
BKS® Uni	763-2081A	FDA UDI	Class II	Active
BKS® Uni	763-6091A	FDA UDI	Class II	Active
BKS® Uni	763-4112	FDA UDI	Class II	Active
BKS E-Vitalize	166-5408	FDA UDI	Class II	Active
BKS E-Vitalize	166-5616	FDA UDI	Class II	Active
BKS E-Vitalize	166-6509	FDA UDI	Class II	Active
BKS E-Vitalize	166-7207	FDA UDI	Class II	Active
BKS® Uni	762-2200	FDA UDI	Class II	Active
Ibis Xl	752-9590-57A	FDA UDI	Class II	Active
BKS® Uni	763-5082A	FDA UDI	Class II	Active
BKS® Uni	763-3092A	FDA UDI	Class II	Active
BKS TriMax	165-3702	FDA UDI	Class II	Active
BKS E-Vitalize	166-6207	FDA UDI	Class II	Active
Ibis Xl	752-7585-57A	FDA UDI	Class II	Active
BKS TriMax PS Plus	166-8112	FDA UDI	Class II	Active
BKS® Uni	763-6081A	FDA UDI	Class II	Active
BKS® Uni	763-2061A	FDA UDI	Class II	Active
BKS TriMax PS Plus	166-8618	FDA UDI	Class II	Active
BKS TriMax PS Plus	166-8711	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.