Cleared Traditional

K945525 - ANSPACH SUTURE ANCHOR

K945525 is an FDA 510(k) clearance for ANSPACH SUTURE ANCHOR, manufactured by The Anspach Effort, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 243-day FDA review.

K945525 · The Anspach Effort, Inc. · Orthopedic device
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Jul 1995
Decision
243d
Days
Class 2
Risk

K945525 is an FDA 510(k) clearance for the ANSPACH SUTURE ANCHOR. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by The Anspach Effort, Inc. (Palm Beach Gardens, US). The FDA issued a Cleared decision on July 11, 1995 after a review of 243 days - an extended review cycle.

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. 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 The Anspach Effort, Inc. devices

FDA 510(k) Submission Details - K945525

510(k) Number K945525 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 1994
Decision Date July 11, 1995
Days to Decision 243 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
121d slower than avg
Panel avg: 122d · This submission: 243d
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 680
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K945525.
SYNTHES (USA) [SYNTHES[ SELF-DRILLING SCHANZ SCREW
K952296 · Synthes (Usa) · Aug 1995
TI. ALLOY 2.0 MM CORTEX SCREW
K952272 · Synthes (Usa) · Jul 1995
REUNION BONE SCREW SYSTEM
K951389 · Smith & Nephew Richards, Inc. · Jul 1995
ABSORBABLE ACETABULAR SCREW
K946347 · Zimmer, Inc. · Jul 1995
DEPUY SET SCREW
K950833 · Depuy, Inc. · Jul 1995
ORTHOPEDIC SCREW FIXATION
K932350 · Osteomed Corp. · Jul 1995