Is this your brand? Sign in to claim ownership.

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 72 of 77

Device	Model / Reference	Registries	Class	Status
Vusion OS	551-6416A	FDA UDI	Class II	Active
Balanced Knee System	162-1500A	FDA UDI	Class II	Active
Balanced Knee System	163-2720	FDA UDI	Class II	Active
Balanced Knee System	163-1112	FDA UDI	Class II	Active
BKS® Uni	763-1111A	FDA UDI	Class II	Active
BKS TriMax	165-3101	FDA UDI	Class II	Active
Balance Knee Revision System	567-2203	FDA UDI	Class II	Active
Legend	175-2862	FDA UDI	Class II	Active
Ibis	752-8555-26	FDA UDI	Class II	Unknown
Ovation Hip Stem	101-1010	FDA UDI	Class II	Active
Escalade Acetabular System	170-3258	FDA UDI	Class II	Active
BKS® Uni	763-1092A	FDA UDI	Class II	Active
Alpine	700-1212A	FDA UDI	Class II	Active
Balanced Knee Revision System	569-2215	FDA UDI	Class II	Active
BKS® Uni	763-8081	FDA UDI	Class II	Active
Pagoda	158-0105A	FDA UDI	Class II	Active
BKS E-Vitalize	166-5112	FDA UDI	Class II	Active
Pisces Spinal System	753-0551	FDA UDI	Class II	Active
Balanced Knee System	161-2501	FDA UDI	Class II	Active
Vusion TS	551-1115	FDA UDI	Class II	Unknown
Ibis Xl	752-8510-57A	FDA UDI	Class II	Active
Envision	154-5465	FDA UDI	Class II	Unknown
BKS® Uni	763-8112A	FDA UDI	Class II	Active
BKS® Uni	763-1091A	FDA UDI	Class II	Active
BKS E-Vitalize	166-6610	FDA UDI	Class II	Active
BKS® Uni	762-5200A	FDA UDI	Class II	Active
Balanced Knee System	161-1304A	FDA UDI	Class II	Active
Solitude Unipolar	132-0059	FDA UDI	Class II	Active
Trivicta	513-1211	FDA UDI	Class II	Active
Vusion OS	551-7613	FDA UDI	Class II	Unknown
Balanced Knee System Revision	567-5201A	FDA UDI	Class II	Active
Balanced Knee System	163-2312	FDA UDI	Class II	Active
Pagoda	752-8570-31	FDA UDI	Class II	Unknown
Entrada Hip Stem	510-0019	FDA UDI	Class II	Active
BKS E-Vitalize	166-5220	FDA UDI	Class II	Active
BKS® Uni	763-2112A	FDA UDI	Class II	Active
Pagoda	158-0060B	FDA UDI	Class II	Active
Ibis	752-7530-41	FDA UDI	Class II	Unknown
Ibis	158-1090-03	FDA UDI	Class II	Unknown
Balanced Knee System	163-1109	FDA UDI	Class II	Active
BKS E-Vitalize	164-5032	FDA UDI	Class II	Active
Tri-plus	138-2206	FDA UDI	Class II	Active
Balanced Knee Revision System	562-7247	FDA UDI	Class II	Active
BKS E-Vitalize	166-7513	FDA UDI	Class II	Active
Balance Knee Revision System	563-1518	FDA UDI	Class II	Active
Pagoda	752-7560-11	FDA UDI	Class II	Unknown
BKS TriMax	165-1252	FDA UDI	Class II	Active
Balanced Knee System	163-3111	FDA UDI	Class II	Active
Balance Knee Revision System	567-7102	FDA UDI	Class II	Active
BKS TriMax	165-3501	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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.