Arex Scru 2 Headless Compression Screws, Models: P2P10, P2P15, P2P20, P2P25, P2P30, P2P35, P2P40, P2P45

Q: What is the product code of K081011?

The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.

FDA 510(k) K081011 · Arex USA

Substantially Equivalent

510(k) numberK081011

Submission

Device name: Arex Scru 2 Headless Compression Screws, Models: P2P10, P2P15, P2P20, P2P25, P2P30, P2P35, P2P40, P2P45
Applicant: Arex USA
Collegeville, PA, US
Received: April 9, 2008
Decision date: November 7, 2008
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: HWC – Screw, Fixation, Bone
Device class: Class II (moderate risk)
Regulation: 21 CFR 888.3040
Specialty: Orthopedic
Implant: Yes

Other 510(k)s with product code HWC

510(k)	Device	Applicant	Decision
K261057	ActivaScrew Cannulated COMHWC · Traditional	Bioretec, Ltd.	09/04/2026SE
K260106	OsteoCoil GT Active Compression SystemHWC · Traditional	Flower Orthopedics Corporation DBA Conventus…	08/24/2026SE
K262344	Large Compression ScrewsHWC · Special	TriMed, Inc.	08/12/2026SE
K253858	GFS - Sterile Screws and Top HatHWC · Special	T.A.G. Medical Products Corporation, Ltd.	08/05/2026SE
K262075	Lapidus Screw KitHWC · Special	Relja Innovations, LLC	07/22/2026SE
K260809	Arthrex Sterile VAL and VAL KreuLock Compression Screw SystemHWC · Traditional	Arthrex, Inc.	06/25/2026SE
K253108	VEOFIX Snap Off ScrewHWC · Traditional	Steps Ortho	06/05/2026SE
K261154	CoLink® & CoLag® Non-Sterile ScrewsHWC · Special	In2Bones USA, LLC	05/30/2026SE
K261241	TriMed Compression ScrewsHWC · Special	TriMed, Inc.	05/14/2026SE
K254215	Arthrex Beaming SystemHWC · Traditional	Arthrex, Inc.	05/08/2026SE

More from Arthrex, Inc.

510(k)	Device	Decision
K122415	X-Fix Dynamic External DistractorHTY · Traditional	03/15/2013SE
K094043	LigamentotaxorHTY · Traditional	08/17/2010SE

Questions and answers

When was Arex Scru 2 Headless Compression Screws, Models: P2P10, P2P15, P2P20, P2P25, P2P30, P2P35, P2P40, P2P45 cleared by the FDA?

Arex Scru 2 Headless Compression Screws, Models: P2P10, P2P15, P2P20, P2P25, P2P30, P2P35, P2P40, P2P45 (K081011) received a 510(k) decision of Substantially Equivalent on November 7, 2008, 212 days after the submission was received.

What is the product code of K081011?

The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.