Cleared Traditional

K925328 - ANSPACH BONE RIVET, ANSPACH SUTURE ANCHOR

K925328 is an FDA 510(k) clearance for ANSPACH BONE RIVET, manufactured by Anspach Mfg., Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 371-day FDA review.

K925328 · Anspach Mfg., Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1993
Decision
371d
Days
Class 2
Risk

K925328 is an FDA 510(k) clearance for the ANSPACH BONE RIVET, ANSPACH SUTURE ANCHOR. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Anspach Mfg., Inc. (Lake Park, US). The FDA issued a Cleared decision on October 27, 1993 after a review of 371 days - an unusually long review period, suggesting complex equivalence evaluation.

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: 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 Anspach Mfg., Inc. devices

FDA 510(k) Submission Details - K925328

510(k) Number K925328 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1992
Decision Date October 27, 1993
Days to Decision 371 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
249d slower than avg
Panel avg: 122d · This submission: 371d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HWC Device Classification - Class 2, Special Controls

Product Code HWC Screw, Fixation, Bone
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 - HWC Screw, Fixation, Bone

All 1029
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K925328.
INSTRUMENT MAKAR PERFIX INTERFERENCE BONE SCREW
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BONE SCREWS
K923841 · Instrument Makar, Inc. · Oct 1993
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K921481 · Acufex Microsurgical, Inc. · Aug 1993
ACUTRACT
K930834 · Acu Med, Inc. · Jul 1993
TECHMEDICA 6.5MM SELF-TAPPING CANCELLOUS BONE SCRE
K926579 · Techmedica, Inc. · Apr 1993