Sirius® Hip System

FDA UDI

Class II (US FDA UDI)

by Biomet Orthopedics, Inc.

Identity

Trade Name: Sirius® Hip System FDA UDI
Generic Name: Uncoated femoral stem prosthesis, one-piece FDA UDI
Model / Reference: 51-199332 FDA UDI

Identifiers

Catalog Number: 51-199332 FDA UDI
Primary DI / UDI-DI: 00887868261664 FDA UDI
510(k) Number: K130610 FDA UDI
FDA Product Code: KWY FDA UDI
LZO FDA UDI
PBI FDA UDI
KWZ FDA UDI
OQG FDA UDI
OQH FDA UDI
MEH FDA UDI
OQI FDA UDI
LZY FDA UDI
JDG FDA UDI
KWL FDA UDI
LPH FDA UDI
JDI FDA UDI
GMDN Term: Uncoated femoral stem prosthesis, one-piece FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3390 FDA UDI
888.3353 FDA UDI
888.3310 FDA UDI
888.3358 FDA UDI
888.3350 FDA UDI
888.3360 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

Category: Uncoated femoral stem prosthesis, one-piece

Sirius® Hip System by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Uncoated femoral stem prosthesis, one-piece.

Consensus Hip System — SHALBY ADVANCED TECHNOLOGIES, INC. · Class III
Consensus Hip System — SHALBY ADVANCED TECHNOLOGIES, INC. · Class III
Alteon — Exactech, Inc. · Class II
OrthoMedFlex — ORTHOMEDFLEX LLC · Class II
Novation — Exactech, Inc. · Class II
Evolve Masters — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
Consensus Hip System — SHALBY ADVANCED TECHNOLOGIES, INC. · Class II
Acumatch C Series — Exactech, Inc. · Class II

Cleared under the same submission

K130610 also covers:

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: Biomet Orthopedics, Inc.

Sources (1)

FDA UDI 7f3b9f30-a814-470e-88b7-801c1fbacb96 36 fields · synced Jun 1, 2026