Shoulder Innovations InSet 95 Humeral Stem

FDA UDI

Class II (US FDA UDI)

by SHOULDER INNOVATIONS, Inc

Identity

Trade Name: Shoulder Innovations InSet 95 Humeral Stem FDA UDI
Generic Name: Total shoulder prosthesis FDA UDI
Device Name: Shoulder Innovations - InSet 95 Humeral Stem - 5x95mm FDA UDI
Model / Reference: 5x95mm FDA UDI
Description: Shoulder Innovations - InSet 95 Humeral Stem - 5x95mm FDA UDI

Identifiers

Catalog Number: 2L1S050001 FDA UDI
Primary DI / UDI-DI: B1132L1S0500010 FDA UDI
510(k) Number: K102670 FDA UDI
K110905 FDA UDI
K111596 FDA UDI
K173824 FDA UDI
FDA Product Code: MBF FDA UDI
HSD FDA UDI
KWT FDA UDI
KWS FDA UDI
GMDN Term: Total shoulder prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3670 FDA UDI
888.3690 FDA UDI
888.3650 FDA UDI
888.3660 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

Sterilization Method

Radiation Sterilization FDA UDI

Category: Total shoulder prosthesis Coated shoulder humeral stem prosthesis

Shoulder Innovations InSet 95 Humeral Stem by SHOULDER INNOVATIONS, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Coated shoulder humeral stem prosthesis.

OsseoFit™ Stemless Shoulder — Zimmer, Inc. · Class II
TORNIER PERFORM™ HUMERAL SYSTEM — TORNIER, INC. · Class II
Tornier HRS — TORNIER, INC. · Class II
Comprehensive® Shoulder System — Biomet Orthopedics, Inc. · Class II
Trabecular Metal® — Zimmer, Inc. · Class II
Comprehensive SRS — Biomet Orthopedics, Inc. · Class II
INHANCE — DEPUY (IRELAND) · Class II
Aequalis™ PerFORM+ — TORNIER, INC. · Class II

Cleared under the same submission

K102670 also covers:

K110905 also covers:

K111596 also covers:

K173824 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

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Manufacturer

Manufacturer: SHOULDER INNOVATIONS, Inc

Sources (1)

FDA UDI 0dbbf076-f26d-44bd-a78d-d4fc38761f07 36 fields · synced Jun 8, 2026