Gentle Threads

FDA UDI

Class II (US FDA UDI)

by Biomet Orthopedics, Inc.

Identity

Trade Name: Gentle Threads FDA UDI
Generic Name: Bioabsorbable orthopaedic bone screw FDA UDI
Model / Reference: 905600 FDA UDI

Identifiers

Catalog Number: 905600 FDA UDI
Primary DI / UDI-DI: 00880304421004 FDA UDI
510(k) Number: K041274 FDA UDI
K982497 FDA UDI
FDA Product Code: HWC FDA UDI
MAI FDA UDI
GMDN Term: Bioabsorbable orthopaedic bone screw FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3040 FDA UDI
888.3030 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

MRI Safety

MR Safe FDA UDI

Category: Bioabsorbable orthopaedic bone screw

Gentle Threads is a bioabsorbable orthopedic bone screw designed for internal fracture fixation, offering a safe and effective way to stabilize bone fragments. Made from chemically degraded materials that are naturally absorbed by the body, Gentle Threads provides superior interfragmentary stabilization and minimizes the risk of complications. With its unique threaded design and smooth slotted head, this implantable device is ideal for various orthopedic procedures.

Similar devices

Also classified as Bioabsorbable orthopaedic bone screw.

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Arthrex® — Arthrex, Inc. · Class II
MILAGRO — Medos International Sàrl · 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 bc7a1b7d-4aca-4ad7-a807-320fee0864f8 36 fields · synced Jul 1, 2026