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Plla, Ha Screw

by Smith & Nephew Inc., Endoscopy Div.

510(k) K080358

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK080358 Date23 Apr 2008ClearedStatusActive

Recalls

2 recalls · 1 ongoing · FDA

    • Ongoing Z-0957-2026 FDA Class II initiated 24 Nov 2025

    Removal of affected lot of screws due to labeling error.

    • Terminated Z-1225-2012 FDA Not yet classified initiated 6 Feb 2012

    Mislabeled: The device was labeled as a standard thread screw (P/N 72201772) on pouch and box, however the device contained in the packaging is a reverse thread screw (P/N 72201773).

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
HWC
Device Class
Class II
Regulation
21 CFR Part 888.3040
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The PLLA/HA Screw is a cannulated, tapered interference screw classified under product code HWC, designed for bone fixation. It is intended for securing bone-tendon-bone or soft tissue grafts during anterior or posterior cruciate ligament (ACL/PCL) reconstruction procedures.

This device is supplied as a sterile, single-use item and is regulated under FDA 510(k) clearance (K080358) with a traditional review pathway. It is intended for use in orthopedic surgery settings and adheres to 21 CFR 888.3040 standards. No additional regulatory markings or MRI safety classifications are specified.

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