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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 25 of 77

Device	Model / Reference	Registries	Class	Status
Vusion PS	551-2010	FDA UDI	Class II	Unknown
Pagoda	752-4540-31	FDA UDI	Class II	Unknown
BKS E-Vitalize	166-7114	FDA UDI	Class II	Active
Tri-plus	138-2609	FDA UDI	Class II	Active
Entrada Hip Stem	510-1012	FDA UDI	Class II	Active
Envision	154-6440	FDA UDI	Class II	Unknown
Escalade Acetabular System	170-0064	FDA UDI	Class II	Active
Solitude Unipolar	132-0054	FDA UDI	Class II	Active
Balanced Knee System Revision	567-5107A	FDA UDI	Class II	Active
Balanced Knee Revision System	569-2408	FDA UDI	Class II	Active
Balanced Knee System	161-3502	FDA UDI	Class II	Active
BKS TriMax	165-1602	FDA UDI	Class II	Active
Balanced Knee Revision System	567-5107	FDA UDI	Class II	Active
Balanced Knee Revision System	563-2416	FDA UDI	Class II	Active
Trivicta	513-0205	FDA UDI	Class II	Active
Pisces Spinal System	753-4540-10A	FDA UDI	Class II	Active
Entrada Hip Stem	510-1214	FDA UDI	Class II	Active
Ibis	752-8535-26	FDA UDI	Class II	Unknown
Balanced Knee Revision System	567-1107	FDA UDI	Class II	Active
Pagoda	752-8530-11	FDA UDI	Class II	Unknown
Pagoda	752-8555-11	FDA UDI	Class II	Unknown
Integrated Spine System	158-3050	FDA UDI	Class II	Unknown
Balance Knee Revision System	563-1210	FDA UDI	Class II	Active
Pagoda	752-7545-11A	FDA UDI	Class II	Active
Tri-plus	138-3230	FDA UDI	Class II	Active
BKS E-Vitalize	166-5708	FDA UDI	Class II	Active
Pagoda	158-3105A	FDA UDI	Class II	Active
Legend	172-3660	FDA UDI	Class II	Active
Ibis	752-5555-41	FDA UDI	Class II	Unknown
Balance Knee Revision System	563-1216	FDA UDI	Class II	Active
BKS® Uni	763-8091	FDA UDI	Class II	Active
Balanced Knee System	163-1313	FDA UDI	Class II	Active
Vusion TS	551-1110	FDA UDI	Class II	Unknown
Delta Ceramic Femoral Head	136-3613	FDA UDI	Class II	Active
Vusion PS	551-2112	FDA UDI	Class II	Unknown
BKS® Uni	761-1801	FDA UDI	Class II	Active
Legend Acetabular Shell	170-0556	FDA UDI	Class II	Active
Vusion TS	551-1010	FDA UDI	Class II	Unknown
Balanced Knee System	161-1506	FDA UDI	Class II	Active
Balanced Knee System	163-1216	FDA UDI	Class II	Active
Balanced Knee Revision System	563-2624	FDA UDI	Class II	Active
Balanced Knee System	161-3607	FDA UDI	Class II	Active
Trivicta	513-1206	FDA UDI	Class II	Active
Vusion TS	551-5014A	FDA UDI	Class II	Active
Balance Knee Revision System	568-1704	FDA UDI	Class II	Active
BKS® Uni	763-1061	FDA UDI	Class II	Active
Pisces Spinal System	753-7530-20	FDA UDI	Class II	Active
Balanced Knee System	163-1308	FDA UDI	Class II	Active
Legend Acetabular Shell	170-0566/A	FDA UDI	Class II	Active
Ibis	752-5545-21A	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.