Solitude Unipolar

FDA UDI

Class II (US FDA UDI)

by Ortho Development Corp.

Identity

Trade Name: Solitude Unipolar FDA UDI
Generic Name: Femoral head/stem prosthesis adaptor FDA UDI
Device Name: 42mm Unipolar FDA UDI
Model / Reference: 132-0042 FDA UDI
Description: 42mm Unipolar FDA UDI

Identifiers

Primary DI / UDI-DI: 00822409014842 FDA UDI
510(k) Number: K042973 FDA UDI
FDA Product Code: KWL FDA UDI
GMDN Term: Femoral head/stem prosthesis adaptor FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 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

Dimensions & Sizes

Size: Outer Diameter — 42 Millimeter FDA UDI

Category: Femoral head/stem prosthesis adaptor

Solitude Unipolar by Ortho Development Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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BIOLOX OPTION HIP SYSTEM — Biomet Orthopedics, Inc. · Class II
CONSERVE® — MicroPort Orthopedics Inc. · Class II
PROFEMUR® — MicroPort Orthopedics Inc. · Class II
BIO-MOORE ENDO II HIP SYSTEM — Biomet Orthopedics, Inc. · Class II

Cleared under the same submission

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

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Manufacturer

Manufacturer: Ortho Development Corp.

Sources (1)

FDA UDI 68ffa072-2401-4698-8edf-5e936f519250 36 fields · synced Jun 8, 2026