Cleared Traditional

K952534 - TENTATIVELY POLARUS EX ROD

K952534 is the FDA 510(k) clearance for TENTATIVELY POLARUS EX ROD by Acu Med, Inc.. It is a Class 2 Orthopedic device (product code HSB) cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K952534 · Acu Med, Inc. · Orthopedic device
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Jul 1995
Decision
42d
Days
Class 2
Risk

K952534 is an FDA 510(k) clearance for the TENTATIVELY POLARUS EX ROD. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Acu Med, Inc. (Beaveton, US). The FDA issued a Cleared decision on July 13, 1995 after a review of 42 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Acu Med, Inc. devices

Submission Details

510(k) Number K952534 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 1995
Decision Date July 13, 1995
Days to Decision 42 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
80d faster than avg
Panel avg: 122d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 322
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K952534.
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
ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
K951673 · Acu Med, Inc. · Jul 1995
TIBIA-TALUS-CALCANEUS NAIL
K950394 · Smith & Nephew Richards, Inc. · May 1995
ALTA FEMORAL INTRAMEDULLARY RODS/CFX RODS MODIFICATION
K935295 · Howmedica Corp. · Oct 1994