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BKS Revision

FDA UDI

Class II (US FDA UDI)

by Ortho Development Corp.

Identity

Trade Name
BKS Revision FDA UDI
Generic Name
Uncoated knee tibia prosthesis, metallic FDA UDI
Device Name
Neutral Tibial Tray Size 7 FDA UDI
Model / Reference
562-1700A FDA UDI
Description
Neutral Tibial Tray Size 7 FDA UDI

Identifiers

Primary DI / UDI-DI
00822409103065 FDA UDI
510(k) Number
K031201 FDA UDI
FDA Product Code
JWH FDA UDI
GMDN Term
Uncoated knee tibia prosthesis, metallic FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3560 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Uncoated knee tibia prosthesis, metallic

The BKS Revision is an uncoated, metallic knee tibia prosthesis designed for primary bicondylar replacement of the knee joint, femoral bone resection, or to replace a dysfunctional knee prosthesis. Its metal construction and lack of coating make it an ideal choice for patients seeking a high-quality, implantable solution.

Similar devices

Also classified as Uncoated knee tibia prosthesis, metallic.

Cleared under the same submission

K031201 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ortho Development Corp.

Sources (1)

  • FDA UDI c434ef31-4ad2-42ac-adb4-5f801c50d01b 35 fields · synced Jun 28, 2026