Cleared Traditional

ANCHORLOK AND ANCHORLOK RL SOFT TISSUE ANCHOR SYSTEM (K971282) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K971282 · Wrightmedicaltechnologyinc · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1997
Decision
81d
Days
Class 2
Risk

K971282 is an FDA 510(k) clearance for the ANCHORLOK AND ANCHORLOK RL SOFT TISSUE ANCHOR SYSTEM. Classified as Fastener, Fixation, Nondegradable, Soft Tissue within the MBI classification (a category for soft tissue fixation fasteners and anchoring systems), Class II - Special Controls.

Submitted by Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on June 27, 1997 after a review of 81 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Wrightmedicaltechnologyinc devices

Submission Details

510(k) Number K971282 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1997
Decision Date June 27, 1997
Days to Decision 81 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 122d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MBI Fastener, Fixation, Nondegradable, Soft Tissue
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - MBI Fastener, Fixation, Nondegradable, Soft Tissue

All 300
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K971282.
CRANIOFACIAL ANCHORS
K974136 · Biomet, Inc. · Jan 1998
CSCO FOREHEAD FIXATION SYSTEM
K963502 · Howmedica Corp. · Oct 1997
FASTAK SUTURE ANCHOR (11.7MM)/(7.5MM)
K971723 · Arthrex, Inc. · Jul 1997
BONE ANCHOR SYSTEM FOR SOFT TISSUE SUPPORT
K971139 · Boston Scientific Corp · Jun 1997
ANCHORLOK RL SOFT TISSUE ANCHOR SYSTEM
K964786 · Wrightmedicaltechnologyinc · Feb 1997
QUESTUS POLYESTER SUTURE SOFT TISSUE ANCHOR SYSTEM
K963200 · Wrightmedicaltechnologyinc · Oct 1996