Cleared Traditional

K102577 - FORCE MEDICAL IM NAIL SYSTEM

K102577 is an FDA 510(k) clearance for FORCE MEDICAL IM NAIL SYSTEM, manufactured by Force Medical, Inc.. The device is a Class 2 Orthopedic device with product code HSB cleared through the Traditional 510(k) pathway after a 603-day FDA review.

K102577 · Force Medical, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2012
Decision
603d
Days
Class 2
Risk

K102577 is an FDA 510(k) clearance for the FORCE MEDICAL IM NAIL SYSTEM. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Force Medical, Inc. (Prior Lake, US). The FDA issued a Cleared decision on May 3, 2012 after a review of 603 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3020 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

FDA 510(k) Submission Details - K102577

510(k) Number K102577 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2010
Decision Date May 03, 2012
Days to Decision 603 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
481d slower than avg
Panel avg: 122d · This submission: 603d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HSB Device Classification - Class 2, Special Controls

Product Code HSB Rod, Fixation, Intramedullary And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3020
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 - HSB Rod, Fixation, Intramedullary And Accessories

All 516
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K102577.
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K120978 · Merete Medical GmbH · May 2012
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K112982 · Small Bone Innovations, Inc. · Apr 2012
ELLIPSE PRECICE TRAUMA NAIL SYSTEM
K113695 · Ellipse Technologies, Inc. · Mar 2012
K102577 · FORCE MEDICAL IM NAIL SYSTEM
Download PDF FDA Summary Force Medical, Inc.