InSitu Hip System

FDA UDI

Class II (US FDA UDI)

by Nextstep Arthropedix

Identity

Trade Name: InSitu Hip System FDA UDI
Generic Name: Coated femoral stem prosthesis, modular FDA UDI
Device Name: Dual Tapered, Femoral Stem, Size 14, Standard FDA UDI
Model / Reference: 10-13-0014 FDA UDI
Description: Dual Tapered, Femoral Stem, Size 14, Standard FDA UDI

Identifiers

Primary DI / UDI-DI: 00816127028298 FDA UDI
FDA Product Code: LPH FDA UDI
LZO FDA UDI
OQG FDA UDI
OQI FDA UDI
GMDN Term: Coated femoral stem prosthesis, modular FDA UDI

Classification

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

Category: Coated femoral stem prosthesis, modular

The InSitu Hip System is a dual tapered, femoral stem, size 14, standard, coated femoral stem prosthesis, modular implantable device designed to replace the proximal femoral neck as part of a total hip arthroplasty (THA). It is composed of two or more separate segments made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel], and is coated with a material [e.g., porous materials, hydroxyapatite] intended to improve fixation and stability by promoting bone ingrowth.

Similar devices

Also classified as Coated femoral stem prosthesis, modular.

MALLORY/HEAD CALCAR HIP SYSTEM — Biomet Orthopedics, Inc. · Class II
STERIZO Total Hip System — CPM Medical Consultants, LLC · Class II
PROFEMUR® — MicroPort Orthopedics Inc. · Class II
MALLORY/HEAD CALCAR HIP SYSTEM — Biomet Orthopedics, Inc. · Class II
Alteon — Exactech, Inc. · Class II
ANTHOLOGY — Smith & Nephew, Inc. · Class III
Origin DAA Stem, Coxa Vara — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
Kyocera Medical Technologies, Inc. — Kyocera Medical Technologies, Inc. · 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

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Manufacturer

Manufacturer: Nextstep Arthropedix

Sources (1)

FDA UDI c9326a48-7a9b-45fe-8ab7-e8aefd61ab43 34 fields · synced Jul 31, 2026