Cleared Traditional

K951116 - ACROMED PEDICLE SCREW

K951116 is an FDA 510(k) clearance for ACROMED PEDICLE SCREW, manufactured by Acromed Corp.. The device is a Class 2 Orthopedic device with product code MNH cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K951116 · Acromed Corp. · Orthopedic device
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Aug 1995
Decision
154d
Days
Class 2
Risk

K951116 is an FDA 510(k) clearance for the ACROMED PEDICLE SCREW. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Acromed Corp. (Cleveland, US). The FDA issued a Cleared decision on August 11, 1995 after a review of 154 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - 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 Acromed Corp. devices

FDA 510(k) Submission Details - K951116

510(k) Number K951116 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received March 10, 1995
Decision Date August 11, 1995
Days to Decision 154 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d slower than avg
Panel avg: 122d · This submission: 154d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MNH Device Classification - Class 2, Special Controls

Product Code MNH Orthosis, Spondylolisthesis Spinal Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
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 - MNH Orthosis, Spondylolisthesis Spinal Fixation

All 170
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K951116.
VSP (VARIABLE SCREW PLACEMENT) SPINAL FIXATION SYSTEM, PEDICLE SCREW(S), SPINE PLATE(S), WASHER(S) & NUT(S)
K951657 · Acromed Corp. · Aug 1995
SYNTHES (USA) UNIV. SCREW FIXATION SYSTEM (TITANIUM)
K951794 · Synthes (Usa) · Aug 1995
WRIGHT-LOC(TM) SPINAL FIXATION SYSTEM
K950074 · Wrightmedicaltechnologyinc · Aug 1995
TITANIUM TSRH(R) SPINAL SYSTEM (SCREWS)
K946348 · Sofamor Danek USA,Inc. · Aug 1995
ISOLA SPINE SYSTEM
K944737 · Acromed Corp. · Jun 1995
SIMMONS PLATING SYSTEM BOLT AND SCREW
K930353 · Smith & Nephew, Inc. · Jun 1995