Cleared Traditional

K940736 - HAIG NAIL

K940736 is an FDA 510(k) clearance for HAIG NAIL, manufactured by Howmedica Corp.. The device is a Class 2 Orthopedic device with product code JDS cleared through the Traditional 510(k) pathway after a 207-day FDA review.

K940736 · Howmedica Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1994
Decision
207d
Days
Class 2
Risk

K940736 is an FDA 510(k) clearance for the HAIG NAIL. Classified as Nail, Fixation, Bone (product code JDS), Class II - Special Controls.

Submitted by Howmedica Corp. (Rutherford, US). The FDA issued a Cleared decision on September 12, 1994 after a review of 207 days - an extended review cycle.

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. 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 Howmedica Corp. devices

FDA 510(k) Submission Details - K940736

510(k) Number K940736 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 1994
Decision Date September 12, 1994
Days to Decision 207 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
85d slower than avg
Panel avg: 122d · This submission: 207d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDS Device Classification - Class 2, Special Controls

Product Code JDS Nail, 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 - JDS Nail, Fixation, Bone

All 41
Devices cleared under the same product code (JDS) and FDA review panel - the closest regulatory comparables to K940736.
SYNTHES (USA) FLEXIBLE HUMERAL NAIL(FLEX NAIL) SYSTEM
K972516 · Synthes (Usa) · Sep 1997
TITANIUM CANNULATED TIBIAL NAIL (TI CTN)
K962047 · Synthes (Usa) · Jul 1996
BONE FIXATION NAIL
K943855 · Acu Med, Inc. · Jul 1995
SEIDEL HUMERAL LOCKING NAIL -- ADDITIONAL LENGTHS
K924004 · Howmedica Corp. · Nov 1992
UNIVERSAL FEMORAL NAIL
K914371 · Synthes (Usa) · Feb 1992
UNIVERSAL TIBIAL NAIL AND UNREAMED TIBIAL NAIL
K914453 · Synthes (Usa) · Feb 1992