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

Catalogue (3843)

Page 22 of 77

Device	Model / Reference	Registries	Class	Status
Escalade Acetabular System	170-2065	FDA UDI	Class II	Active
Pagoda	752-5525-11	FDA UDI	Class II	Unknown
Balanced Knee Revision System	563-2112	FDA UDI	Class II	Active
Vusion OS	551-7411A	FDA UDI	Class II	Active
Ovation Hip Stem	101-1202	FDA UDI	Class II	Active
Balanced Knee System Revision	567-7207A	FDA UDI	Class II	Active
Balanced Knee Revision System	568-2502	FDA UDI	Class II	Active
BKS® Uni	763-6061	FDA UDI	Class II	Active
BKS® Uni	762-6100A	FDA UDI	Class II	Active
BKS® Uni	763-8092	FDA UDI	Class II	Active
Balance Knee Revision System	563-1218	FDA UDI	Class II	Active
Ibis	752-4535-41	FDA UDI	Class II	Unknown
Balanced Knee System Revision	567-7202A	FDA UDI	Class II	Active
Legend	172-3262	FDA UDI	Class II	Active
Trivicta	513-1003	FDA UDI	Class II	Active
Balanced Knee Revision System	563-2122	FDA UDI	Class II	Active
Vusion OS	551-7615A	FDA UDI	Class II	Active
Solitude Unipolar	132-1206	FDA UDI	Class II	Active
Balanced Knee System	163-3514	FDA UDI	Class II	Active
Balanced Knee System	163-5514	FDA UDI	Class II	Active
Entrada Hip Stem	510-0216	FDA UDI	Class II	Active
Ibis	752-5540-41	FDA UDI	Class II	Unknown
Balanced Knee System	161-3506	FDA UDI	Class II	Active
Balanced Knee System	161-1403A	FDA UDI	Class II	Active
Balance Knee Revision System	568-2304	FDA UDI	Class II	Active
Legend	174-3660	FDA UDI	Class II	Active
Balanced Knee System Revision	568-1212A	FDA UDI	Class II	Active
Vusion PS	551-5112	FDA UDI	Class II	Unknown
Vusion CS Plus	159-1206-07A	FDA UDI	Class II	Active
Legend Acetabular Shell	170-0552	FDA UDI	Class II	Active
Pagoda	752-7560-12A	FDA UDI	Class II	Active
Pagoda	752-7530-12A	FDA UDI	Class II	Active
Balance Knee Revision System	563-1414	FDA UDI	Class II	Active
Pagoda	752-6535-11A	FDA UDI	Class II	Active
Vusion OS	551-6207A	FDA UDI	Class II	Active
Vusion OS	551-7511A	FDA UDI	Class II	Active
Ovation Hip Stem	101-0001	FDA UDI	Class II	Active
Balanced Knee Revision System	562-5252	FDA UDI	Class II	Active
Legend Acetabular Shell	170-0446/A	FDA UDI	Class II	Active
Balance Knee Revision System	566-1715	FDA UDI	Class II	Active
Ibis	752-8530-26A	FDA UDI	Class II	Active
Legend Acetabular Shell	170-0656	FDA UDI	Class II	Active
BKS® Uni	763-7101	FDA UDI	Class II	Active
Balance Knee Revision System	562-2600	FDA UDI	Class II	Active
Ibis	752-6540-41A	FDA UDI	Class II	Active
Balanced Knee System	161-1603	FDA UDI	Class II	Active
Alpine Hip System	700-0011	FDA UDI	Class II	Active
Escalade Acetabular System	171-2858	FDA UDI	Class II	Active
Vusion OS	551-7215	FDA UDI	Class II	Unknown
BKS® Uni	763-7112A	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.