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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 12 of 77

Device	Model / Reference	Registries	Class	Status
Balanced Knee System	161-3202A	FDA UDI	Class II	Active
Balanced Knee System	163-3412	FDA UDI	Class II	Active
Encompass Hip Stem	106-0014	FDA UDI	Class II	Active
Entrada Hip Stem	510-0018	FDA UDI	Class II	Active
Ibis	158-0040-03A	FDA UDI	Class II	Active
Pisces Spinal System	753-6535-20	FDA UDI	Class II	Active
Vusion OS	551-7213	FDA UDI	Class II	Unknown
Balanced Knee System	163-2308	FDA UDI	Class II	Active
Balance Knee Revision System	561-1602	FDA UDI	Class II	Active
Balanced Knee Revision System	561-5046	FDA UDI	Class II	Active
Ibis Xl	752-8575-57A	FDA UDI	Class II	Active
BKS® Uni	761-1802	FDA UDI	Class II	Active
Pagoda	158-0105-01A	FDA UDI	Class II	Active
Balanced Knee Revision System	562-7252	FDA UDI	Class II	Active
Legend	173-2860	FDA UDI	Class II	Active
BKS TriMax PS Plus	166-8111	FDA UDI	Class II	Active
Pisces Spinal System	753-5545-10A	FDA UDI	Class II	Active
Pagoda	752-7590-31	FDA UDI	Class II	Unknown
Ibis	752-8550-41	FDA UDI	Class II	Unknown
Pagoda	752-6555-11	FDA UDI	Class II	Unknown
Balanced Knee Revision System	563-2312	FDA UDI	Class II	Active
BKS® Uni	761-1401	FDA UDI	Class II	Active
Vusion TS	551-5015A	FDA UDI	Class II	Active
Balanced Knee System Revision	568-2202A	FDA UDI	Class II	Active
Vusion OS	551-6315	FDA UDI	Class II	Unknown
Pagoda	158-3070A	FDA UDI	Class II	Active
Legend	175-4060	FDA UDI	Class II	Active
Balanced Knee System	163-2708	FDA UDI	Class II	Active
Integrated Spine System	158-7580-01	FDA UDI	Class II	Unknown
BKS E-Vitalize	166-6413	FDA UDI	Class II	Active
Vusion CS Plus	159-1207-00	FDA UDI	Class II	Unknown
Envision	154-6016	FDA UDI	Class II	Unknown
Escalade Acetabular System	170-0352	FDA UDI	Class II	Active
Legend Acetabular Shell	170-0560/A	FDA UDI	Class II	Active
Pisces Spinal System	753-8555-10A	FDA UDI	Class II	Active
Pagoda	158-0055-01	FDA UDI	Class II	Unknown
Balanced Knee System	164-0035	FDA UDI	Class II	Active
Legend Acetabular Shell	170-0466/A	FDA UDI	Class II	Active
Vusion OS	551-6710A	FDA UDI	Class II	Active
BKS® Uni	763-5091	FDA UDI	Class II	Active
Pagoda	158-0040A	FDA UDI	Class II	Active
Balanced Knee System	161-1101A	FDA UDI	Class II	Active
Vusion OS	551-7415A	FDA UDI	Class II	Active
Balance Knee Revision System	561-1701	FDA UDI	Class II	Active
Balance Knee Revision System	562-1200	FDA UDI	Class II	Active
Pagoda	752-6540-31A	FDA UDI	Class II	Active
Balance Knee Revision System	567-1101	FDA UDI	Class II	Active
Ibis	752-8555-21	FDA UDI	Class II	Unknown
Legend Acetabular Shell	170-0644	FDA UDI	Class II	Active
BKS TriMax PS Plus	166-8312	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.