Compress Device

FDA UDI

Class II (US FDA UDI)

by Biomet Orthopedics, Inc.

Identity

Trade Name: Compress Device FDA UDI
Generic Name: Orthopaedic bone pin, non-bioabsorbable FDA UDI
Model / Reference: 178524 FDA UDI

Identifiers

Catalog Number: 178524 FDA UDI
Primary DI / UDI-DI: 00880304260498 FDA UDI
510(k) Number: K031804 FDA UDI
K043547 FDA UDI
FDA Product Code: JDI FDA UDI
KWY FDA UDI
KRO FDA UDI
MEH FDA UDI
KWZ FDA UDI
LPH FDA UDI
LZO FDA UDI
GMDN Term: Orthopaedic bone pin, non-bioabsorbable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3350 FDA UDI
888.3390 FDA UDI
888.3510 FDA UDI
888.3353 FDA UDI
888.3310 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

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Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Orthopaedic bone pin, non-bioabsorbable

The Compress Device is a high-quality, implantable rod designed for the stabilization of bone fractures or bone grafts, as well as osteotomies or arthrodesis. Made from non-bioabsorbable materials like stainless steel, it features a break-off shank and/or improved long-term fixation with coatings. This single-use device is intended for orthopedic procedures in patients with limited range of motion.

Similar devices

Also classified as Orthopaedic bone pin, non-bioabsorbable.

Steinmann Pins, K-Wire, smooth — Gebr. Brasseler GmbH & Co. KG · Class II
KW03-310-18.A — newbox medical GmbH · Class IIb
Steinmann Pins, K-Wire, smooth — Gebr. Brasseler GmbH & Co. KG · Class II
IlluminOss — ILLUMINOSS MEDICAL INC. · Class II
XtraFix® External Fixation System — Zimmer, Inc. · Class II
SMART TSF — Smith & Nephew, Inc. · Class II
KW02-300-20.A — newbox medical GmbH · Class IIb
SMART TSF — Smith & Nephew, 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: Biomet Orthopedics, Inc.

Sources (1)

FDA UDI f3f42328-43e6-4e9d-bada-8dfb4fbb9906 36 fields · synced Jul 26, 2026