Cleared Traditional

K952739 - ORTHONAIL

K952739 is an FDA 510(k) clearance for ORTHONAIL, manufactured by Orthologic Corp.. The device is a Class 2 Orthopedic device with product code HSB cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K952739 · Orthologic Corp. · Orthopedic device
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Sep 1995
Decision
92d
Days
Class 2
Risk

K952739 is an FDA 510(k) clearance for the ORTHONAIL. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Orthologic Corp. (Phoenix, US). The FDA issued a Cleared decision on September 15, 1995 after a review of 92 days - within the typical 510(k) review window.

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: 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 Orthologic Corp. devices

FDA 510(k) Submission Details - K952739

510(k) Number K952739 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 1995
Decision Date September 15, 1995
Days to Decision 92 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
30d faster than avg
Panel avg: 122d · This submission: 92d
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 461
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K952739.
ALTA TIBIAL/HUMERAL ROD
K954554 · Howmedica Corp. · Dec 1995
SYNTHES FLEXNAIL
K953334 · Synthes (Usa) · Oct 1995
INTRAMEDULLARY COMPRESSION ARTHRODESIS (ICA) NAIL
K952923 · Howmedica Corp. · Sep 1995
INTRAMEDULARY FIXATION ROD
K951740 · Acu Med, Inc. · Aug 1995
TENTATIVELY POLARUS EX ROD
K952534 · Acu Med, Inc. · Jul 1995
ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
K951673 · Acu Med, Inc. · Jul 1995