BKS TriMax PS Plus

FDA UDI

Class II (US FDA UDI)

by Ortho Development Corp.

Identity

Trade Name: BKS TriMax PS Plus FDA UDI
Generic Name: Tibial insert FDA UDI
Device Name: PS Plus Insert Size 4 18mm SFP FDA UDI
Model / Reference: 166-8418 FDA UDI
Description: PS Plus Insert Size 4 18mm SFP FDA UDI

Identifiers

Primary DI / UDI-DI: 00822409124916 FDA UDI
FDA Product Code: JWH FDA UDI
GMDN Term: Tibial insert 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

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Height — 18 Millimeter FDA UDI

Category: Tibial insert

BKS TriMax PS Plus by Ortho Development Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Tibial insert.

DJO SURGICAL — ENCORE MEDICAL, L.P. · Class II
P.F.C. SIGMA — DEPUY (IRELAND) · Class II
Truliant, Activit-E — Exactech, Inc. · Class II
Maxim Knee System — Biomet Orthopedics, Inc. · Class II
Scorpio — Howmedica Osteonics Corp. · Class II
TriVerse Meniscal Insert PS+ — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
Scorpio — Howmedica Osteonics Corp. · Class II
World Knee System — SIGNATURE ORTHOPAEDICS PTY LTD · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Ortho Development Corp.

Sources (1)

FDA UDI c356c674-b240-4217-a6f7-ce84ea2d4c6e 35 fields · synced May 31, 2026