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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 7 of 77

Device	Model / Reference	Registries	Class	Status
Balance Knee Revision System	567-7104	FDA UDI	Class II	Active
Alpine	700-1215A	FDA UDI	Class II	Active
Vusion OS	551-6714	FDA UDI	Class II	Unknown
Balanced Knee System	163-2120	FDA UDI	Class II	Active
Balanced Knee Revision System	562-3400A	FDA UDI	Class II	Active
Balance Knee Revision System	566-1711	FDA UDI	Class II	Active
Entrada Hip Stem	510-1216	FDA UDI	Class II	Active
BKS E-Vitalize	166-6114	FDA UDI	Class II	Active
BKS E-Vitalize	166-6613	FDA UDI	Class II	Active
Ibis	752-6555-21A	FDA UDI	Class II	Active
Envision	154-5238	FDA UDI	Class II	Unknown
Balanced Knee System	161-4602	FDA UDI	Class II	Active
Balanced Knee System	163-3210	FDA UDI	Class II	Active
Ibis	752-6555-41A	FDA UDI	Class II	Active
Ibis	752-6560-26A	FDA UDI	Class II	Active
Balanced Knee System	163-3416	FDA UDI	Class II	Active
Ibis	158-0050-03	FDA UDI	Class II	Unknown
Vusion CS Plus	159-1606-07A	FDA UDI	Class II	Active
Ibis	158-0035-03A	FDA UDI	Class II	Active
BKS® Uni	762-6200	FDA UDI	Class II	Active
Balanced Knee System	164-0038	FDA UDI	Class II	Active
Pisces Spinal System	753-4550-10A	FDA UDI	Class II	Active
Integrated Spine System	158-0090	FDA UDI	Class II	Unknown
Balance Knee Revision System	562-3300	FDA UDI	Class II	Active
BKS® Uni	763-3071A	FDA UDI	Class II	Active
Pagoda	158-0150B	FDA UDI	Class II	Active
Vusion OS	551-6414A	FDA UDI	Class II	Active
12/14 CoCr Femoral Head	138-4000	FDA UDI	Class II	Active
Balanced Knee System Revision	568-1204A	FDA UDI	Class II	Active
Balance Knee Revision System	566-1815	FDA UDI	Class II	Active
Ibis	752-8535-41	FDA UDI	Class II	Unknown
BKS® Uni	762-3200A	FDA UDI	Class II	Active
Balanced Knee System	161-1204A	FDA UDI	Class II	Active
Trivicta	513-0010	FDA UDI	Class II	Active
Pisces Spinal System	753-5550-20	FDA UDI	Class II	Active
Pagoda	752-7530-11	FDA UDI	Class II	Unknown
Vusion CS Plus	159-1605-07	FDA UDI	Class II	Unknown
Encompass Hip Stem	107-1017	FDA UDI	Class II	Active
Pivot Bipolar	133-2859	FDA UDI	Class II	Active
Balanced Knee System	163-3107	FDA UDI	Class II	Active
Encompass Hip Stem	106-0012	FDA UDI	Class II	Active
Legend	173-2842	FDA UDI	Class II	Active
BKS E-Vitalize	166-5620	FDA UDI	Class II	Active
Pisces Spinal System	753-6555-10A	FDA UDI	Class II	Active
Ibis	752-8560-21A	FDA UDI	Class II	Active
BKS E-Vitalize	166-5309	FDA UDI	Class II	Active
Balanced Knee Revision System	562-2500A	FDA UDI	Class II	Active
Vusion OS	551-6610A	FDA UDI	Class II	Active
Balance Knee Revision System	567-7105	FDA UDI	Class II	Active
Balanced Knee System	161-2601	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.