InSitu Hip System

FDA UDI

Class II (US FDA UDI)

by Nextstep Arthropedix

Identity

Trade Name: InSitu Hip System FDA UDI
Generic Name: Press-fit hip femur prosthesis, modular FDA UDI
Device Name: Femoral Stem, Size 1, Lateralized FDA UDI
Model / Reference: 10-11-0001 FDA UDI
Description: Femoral Stem, Size 1, Lateralized FDA UDI

Identifiers

Catalog Number: 10-11-0001 FDA UDI
Primary DI / UDI-DI: 00816127022081 FDA UDI
510(k) Number: K161184 FDA UDI
FDA Product Code: OQI FDA UDI
OQG FDA UDI
LZO FDA UDI
LPH FDA UDI
GMDN Term: Press-fit hip femur prosthesis, modular FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3353 FDA UDI
888.3358 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

Yes

FDA UDI

Dimensions & Sizes

Size: Length — 115 Millimeter FDA UDI

Category: Press-fit hip femur prosthesis, modular

InSitu Hip System by Nextstep Arthropedix — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Press-fit hip femur prosthesis, modular.

Perfecta — MicroPort Orthopedics Inc. · Class III
Alloclassic® Zweymüller® — Zimmer, Inc. · Class II
Wagner SL Revision® — Zimmer, Inc. · Class II
VerSys® — Zimmer, Inc. · Class II
Wagner Cone Prosthesis® — Zimmer, Inc. · Class II
SUMMIT — DEPUY ORTHOPAEDICS, INC. · Class II
Profemur — MicroPort Orthopedics Inc. · Class III
Alloclassic® Zweymüller® — Zimmer, 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: Nextstep Arthropedix

Sources (1)

FDA UDI 34b7fbc6-cc18-407a-9b71-323fb18aa0c8 37 fields · synced May 30, 2026