Cleared Traditional

ANSPACH SUTURE ANCHOR (MODIFIED) (K963686) - FDA 510(k) Clearance

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

K963686 · The Anspach Effort, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1996
Decision
74d
Days
Class 2
Risk

K963686 is an FDA 510(k) clearance for the ANSPACH SUTURE ANCHOR (MODIFIED). 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 The Anspach Effort, Inc. (Palm Beach Gardens, US). The FDA issued a Cleared decision on November 25, 1996 after a review of 74 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 The Anspach Effort, Inc. devices

Submission Details

510(k) Number K963686 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 1996
Decision Date November 25, 1996
Days to Decision 74 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 122d · This submission: 74d
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 302
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K963686.
ANCHORLOK AND ANCHORLOK RL SOFT TISSUE ANCHOR SYSTEM
K971282 · Wrightmedicaltechnologyinc · Jun 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
ANCHORLOK II SOFT TISSUE ANCHOR SYSTEM
K963217 · Wrightmedicaltechnologyinc · Oct 1996
STATAK SOFT TISSUE ATTACHMENT DEVICE
K962397 · Zimmer, Inc. · Aug 1996