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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 4 of 77

Device	Model / Reference	Registries	Class	Status
BKS® Uni	763-4102	FDA UDI	Class II	Active
Ibis	752-6560-21	FDA UDI	Class II	Unknown
Delta Ceramic Femoral Head	136-3600	FDA UDI	Class II	Active
Pagoda	752-8560-11A	FDA UDI	Class II	Active
BKS® Uni	763-7072	FDA UDI	Class II	Active
BKS® Uni	763-1091	FDA UDI	Class II	Active
Vusion OS	551-6110	FDA UDI	Class II	Unknown
Ibis	158-0035-03	FDA UDI	Class II	Unknown
Vusion PS	551-5413	FDA UDI	Class II	Unknown
BKS® Uni	763-1112A	FDA UDI	Class II	Active
Pagoda	752-6550-11A	FDA UDI	Class II	Active
Balance Knee Revision System	566-2215	FDA UDI	Class II	Active
Vusion OS	551-6116A	FDA UDI	Class II	Active
Ibis	158-1055-03A	FDA UDI	Class II	Active
Balanced Knee System	163-2407	FDA UDI	Class II	Active
Entrada Hip Stem	510-1220	FDA UDI	Class II	Active
BKS E-Vitalize	166-6418	FDA UDI	Class II	Active
Balanced Knee System	163-5111	FDA UDI	Class II	Active
BKS E-Vitalize	166-5209	FDA UDI	Class II	Active
Envision	154-6012	FDA UDI	Class II	Unknown
BKS TriMax PS Plus	166-8109	FDA UDI	Class II	Active
Balance Knee Revision System	568-1512	FDA UDI	Class II	Active
Legend	174-3264	FDA UDI	Class II	Active
BKS TriMax PS Plus	166-8210	FDA UDI	Class II	Active
Biolox Delta	136-3601	FDA UDI	Class II	Active
Balanced Knee System	163-2307	FDA UDI	Class II	Active
BKS TriMax PS Plus	166-8709	FDA UDI	Class II	Active
12/14 CoCr Femoral Head	138-4009	FDA UDI	Class II	Active
Ibis	158-0070-03A	FDA UDI	Class II	Active
Trivicta	513-0006	FDA UDI	Class II	Active
Vusion PS	551-5211	FDA UDI	Class II	Unknown
Envision	154-5355	FDA UDI	Class II	Unknown
Balanced Knee System	163-5209	FDA UDI	Class II	Active
BKS® Uni	763-4081A	FDA UDI	Class II	Active
Balanced Knee Revision System	569-1308	FDA UDI	Class II	Active
Envision	154-5118	FDA UDI	Class II	Unknown
Balanced Knee System	163-5616	FDA UDI	Class II	Active
BKS E-Vitalize	166-7309	FDA UDI	Class II	Active
Pagoda	752-5535-31A	FDA UDI	Class II	Active
Vusion OS	551-7513	FDA UDI	Class II	Unknown
Balanced Knee System	161-2102	FDA UDI	Class II	Active
Balanced Knee System	163-5308	FDA UDI	Class II	Active
Escalade Acetabular System	171-2848	FDA UDI	Class II	Active
Balance Knee Revision System	567-6206	FDA UDI	Class II	Active
Balanced Knee System Revision	567-5101A	FDA UDI	Class II	Active
Balance Knee Revision System	568-2708	FDA UDI	Class II	Active
Encompass Hip Stem	106-0011	FDA UDI	Class II	Active
Balanced Knee Revision System	563-2220	FDA UDI	Class II	Active
Vusion CS Plus	159-1608-07	FDA UDI	Class II	Unknown
Trivicta	513-0001	FDA UDI	Class II	Active

Related Companies

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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.