Cleared Traditional

K951658 - LACTOSORB POP RIVET

K951658 is an FDA 510(k) clearance for LACTOSORB POP RIVET, manufactured by Poly-Medics,Inc.. The device is a Class 2 Orthopedic device with product code JDR cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K951658 · Poly-Medics,Inc. · Orthopedic device
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Jul 1995
Decision
106d
Days
Class 2
Risk

K951658 is an FDA 510(k) clearance for the LACTOSORB POP RIVET. 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 July 25, 1995 after a review of 106 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

FDA 510(k) Submission Details - K951658

510(k) Number K951658 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received April 10, 1995
Decision Date July 25, 1995
Days to Decision 106 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 122d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDR Device Classification - Class 2, Special Controls

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 160
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K951658.
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LMT BONE ANCHOR
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ETHICON NONABSORBABLE SUTURE ANCHOR
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MITEK TOGGLE ANCHOR(TM)
K950070 · Mitek Surgical Products, Inc. · May 1995
ACUFEX TAG(R) BIOABSORBABLE ANCHORS
K946346 · Acufex Microsurgical, Inc. · Apr 1995