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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 20 of 77

Device	Model / Reference	Registries	Class	Status
Balanced Knee System	163-2507	FDA UDI	Class II	Active
Legend	175-3248	FDA UDI	Class II	Active
Legend	175-4056	FDA UDI	Class II	Active
Legend	173-3652	FDA UDI	Class II	Active
Pagoda	752-7545-31	FDA UDI	Class II	Unknown
Ibis	158-1065-03A	FDA UDI	Class II	Active
Escalade Acetabular System	170-0142	FDA UDI	Class II	Active
Balanced Knee System	161-1602	FDA UDI	Class II	Active
Balanced Knee Revision System	567-5207	FDA UDI	Class II	Active
Balanced Knee System Revision	568-2504A	FDA UDI	Class II	Active
Legend	173-4062	FDA UDI	Class II	Active
Balanced Knee System Revision	568-2608A	FDA UDI	Class II	Active
Legend	175-4062	FDA UDI	Class II	Active
Balanced Knee System	162-5300	FDA UDI	Class II	Active
BKS® Uni	763-3061	FDA UDI	Class II	Active
Legend Acetabular Shell	170-0662	FDA UDI	Class II	Active
Vusion OS	551-6209A	FDA UDI	Class II	Active
Balance Knee Revision System	566-1611	FDA UDI	Class II	Active
Legend Acetabular Shell	170-0648	FDA UDI	Class II	Active
Legend	173-3248	FDA UDI	Class II	Active
BKS TriMax PS Plus	166-8511	FDA UDI	Class II	Active
Balanced Knee Revision System	563-2324	FDA UDI	Class II	Active
Pisces Spinal System	753-5545-20	FDA UDI	Class II	Active
Vusion PS	551-5108	FDA UDI	Class II	Unknown
Pisces Spinal System	753-6525-10A	FDA UDI	Class II	Active
Ibis	752-4520-21	FDA UDI	Class II	Unknown
Pagoda	752-8535-12	FDA UDI	Class II	Unknown
Vusion TS	551-5207A	FDA UDI	Class II	Active
BKS® Uni	763-5072A	FDA UDI	Class II	Active
Surespace	SST2058	FDA UDI	Class II	Active
BKS® Uni	763-6071	FDA UDI	Class II	Active
Pagoda	752-6545-31A	FDA UDI	Class II	Active
Balance Knee Revision System	563-1220	FDA UDI	Class II	Active
Balanced Knee System	163-5512	FDA UDI	Class II	Active
Balanced Knee System	162-1100A	FDA UDI	Class II	Active
Pagoda	752-8545-12	FDA UDI	Class II	Unknown
Balanced Knee System Revision	567-7203A	FDA UDI	Class II	Active
Balanced Knee Revision System	563-2420	FDA UDI	Class II	Active
Delta Ceramic Femoral Head	136-3230	FDA UDI	Class II	Active
Pagoda	752-0006	FDA UDI	Class II	Unknown
Vusion PS	551-2109	FDA UDI	Class II	Unknown
Ibis	752-4540-41	FDA UDI	Class II	Unknown
Balanced Knee System	163-5216	FDA UDI	Class II	Active
Vusion CS Plus	159-1408-00	FDA UDI	Class II	Unknown
Balanced Knee System	163-2109	FDA UDI	Class II	Active
Ibis	158-1035-03	FDA UDI	Class II	Unknown
Pisces Spinal System	753-4530-20	FDA UDI	Class II	Active
Balanced Knee System	161-4201	FDA UDI	Class II	Active
Balanced Knee System	163-3112	FDA UDI	Class II	Active
Balanced Knee System	163-1318	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.