Cleared Traditional

K921338 - ANSPACH MINI-PLATING SYSTEM

K921338 is an FDA 510(k) clearance for ANSPACH MINI-PLATING SYSTEM, manufactured by The Anspach Effort, Inc.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 329-day FDA review.

K921338 · The Anspach Effort, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Feb 1993
Decision
329d
Days
Class 2
Risk

K921338 is an FDA 510(k) clearance for the ANSPACH MINI-PLATING SYSTEM. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by The Anspach Effort, Inc. (Lake Park, US). The FDA issued a Cleared decision on February 10, 1993 after a review of 329 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 The Anspach Effort, Inc. devices

FDA 510(k) Submission Details - K921338

510(k) Number K921338 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1992
Decision Date February 10, 1993
Days to Decision 329 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
207d slower than avg
Panel avg: 122d · This submission: 329d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRS Device Classification - Class 2, Special Controls

Product Code HRS Plate, 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 - HRS Plate, Fixation, Bone

All 1005
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K921338.
LUHR MINI BONE SCREW AND Z PLATE
K935448 · Howmedica Corp. · Feb 1994
BONE PLATE
K931244 · Acu Med, Inc. · Feb 1994
LUHR PAN FIXATION SYSTEM
K923861 · Howmedica Corp. · Mar 1993
DALL MILES BROAD BONE PLATE
K922525 · Howmedica Corp. · Sep 1992
TMP MICROPLATING SYSTEM
K921458 · Techmedica, Inc. · Jul 1992
SYNTHES(R) TITANIUM SMALL RECONSTRUCTION PLATE
K915818 · Synthes (Usa) · Jan 1992