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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 15 of 77

Device	Model / Reference	Registries	Class	Status
Ibis	752-4550-41	FDA UDI	Class II	Unknown
Entrada Hip Stem	510-0217	FDA UDI	Class II	Active
BKS E-Vitalize	166-5714	FDA UDI	Class II	Active
BKS Revision	562-1200A	FDA UDI	Class II	Active
BKS® Uni	763-3081	FDA UDI	Class II	Active
Legend	175-3654	FDA UDI	Class II	Active
Pagoda	752-5550-31	FDA UDI	Class II	Unknown
Vusion OS	551-7609	FDA UDI	Class II	Unknown
Integrated Spine System	158-0135	FDA UDI	Class II	Unknown
Balanced Knee System	163-2716	FDA UDI	Class II	Active
Ibis	752-7535-26A	FDA UDI	Class II	Active
Balance Knee Revision System	563-1430	FDA UDI	Class II	Active
Balance Knee Revision System	567-5205	FDA UDI	Class II	Active
Balance Knee Revision System	566-2008	FDA UDI	Class II	Active
Legend	175-3662	FDA UDI	Class II	Active
Pagoda	752-0102A	FDA UDI	Class II	Active
Ibis	752-6545-21A	FDA UDI	Class II	Active
Balance Knee Revision System	566-2015	FDA UDI	Class II	Active
Pagoda	752-4530-11	FDA UDI	Class II	Unknown
Balanced Knee System	163-2518	FDA UDI	Class II	Active
Ibis	752-5550-26A	FDA UDI	Class II	Active
Pagoda	752-0202A	FDA UDI	Class II	Active
Escalade Acetabular System	170-3060	FDA UDI	Class II	Active
Balanced Knee System	163-5116	FDA UDI	Class II	Active
Surespace	SSF1075	FDA UDI	Class II	Active
BKS® Uni	763-7092	FDA UDI	Class II	Active
Balanced Knee System Revision	567-5103A	FDA UDI	Class II	Active
Vusion TS	551-5208	FDA UDI	Class II	Unknown
Pagoda	752-8590-31	FDA UDI	Class II	Unknown
Vusion OS	551-7610	FDA UDI	Class II	Unknown
Balanced Knee System	163-2513	FDA UDI	Class II	Active
Vusion OS	551-6209	FDA UDI	Class II	Unknown
Legend Acetabular Shell	170-0446	FDA UDI	Class II	Active
Vusion PS	551-5213	FDA UDI	Class II	Unknown
Balanced Knee System	161-1407	FDA UDI	Class II	Active
Vusion PS	551-5318	FDA UDI	Class II	Unknown
Vusion OS	551-6512	FDA UDI	Class II	Unknown
Escalade Acetabular System	170-2035	FDA UDI	Class II	Active
Ovation	101-1406	FDA UDI	Class II	Active
BKS TriMax	165-3405	FDA UDI	Class II	Active
Pisces Spinal System	753-7540-10A	FDA UDI	Class II	Active
BKS E-Vitalize	166-5313	FDA UDI	Class II	Active
Balanced Knee System	163-3520	FDA UDI	Class II	Active
Vusion TS	551-5008A	FDA UDI	Class II	Active
BKS E-Vitalize	166-6408	FDA UDI	Class II	Active
BKS® Uni	763-3072A	FDA UDI	Class II	Active
BKS TriMax	165-3506	FDA UDI	Class II	Active
Balance Knee Revision System	567-6102	FDA UDI	Class II	Active
Encompass Hip Stem	114-0015	FDA UDI	Class II	Active
Alpine Hip System	700-0015	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.