Cleared Traditional

LACTOSORB SUTURE ANCHOR (K954443) - FDA 510(k) Clearance

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

K954443 · Poly-Medics,Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1996
Decision
128d
Days
Class 2
Risk

K954443 is an FDA 510(k) clearance for the LACTOSORB SUTURE ANCHOR. Classified as Staple, Fixation, Bone (product code JDR), Class II - Special Controls.

Submitted by Poly-Medics,Inc. (Warsaw, US). The FDA issued a Cleared decision on January 31, 1996 after a review of 128 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Poly-Medics,Inc. devices

Submission Details

510(k) Number K954443 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received September 25, 1995
Decision Date January 31, 1996
Days to Decision 128 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 122d · This submission: 128d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JDR Staple, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - JDR Staple, Fixation, Bone

All 65
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K954443.
HOWMEDICA MAINSTAY ANCHOR
K965175 · Howmedica Corp. · Mar 1997
SUTURE ANCHOR
K961578 · United States Surgical, A Division of Tyco Healthc · Jul 1996
SURGICAL DYNAMICS POP RIVET
K961585 · United States Surgical, A Division of Tyco Healthc · Jul 1996
PANALOK ABSORBABLE SUTURE ANCHOR SYSTEM
K950272 · Ethicon, Inc. · Jan 1996
HOWMEDICA MAINSTAY ANCHOR
K953531 · Howmedica Corp. · Sep 1995
ETHICON NONABSORBABLE SUTURE ANCHOR
K943950 · Ethicon, Inc. · May 1995