Cleared Traditional

K973385 - OVAL SHAPES

K973385 is an FDA 510(k) clearance for OVAL SHAPES, manufactured by Technical Products, Inc.. The device is a Class 2 Orthopedic device with product code HXA cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K973385 · Technical Products, Inc. · Orthopedic device
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Dec 1997
Decision
88d
Days
Class 2
Risk

K973385 is an FDA 510(k) clearance for the OVAL SHAPES. Classified as Prosthesis, Tendon, Passive (product code HXA), Class II - Special Controls.

Submitted by Technical Products, Inc. (Decatur, US). The FDA issued a Cleared decision on December 5, 1997 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3025 - 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 Technical Products, Inc. devices

FDA 510(k) Submission Details - K973385

510(k) Number K973385 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 1997
Decision Date December 05, 1997
Days to Decision 88 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
34d faster than avg
Panel avg: 122d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HXA Device Classification - Class 2, Special Controls

Product Code HXA Prosthesis, Tendon, Passive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3025
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 - HXA Prosthesis, Tendon, Passive

All 8
Devices cleared under the same product code (HXA) and FDA review panel - the closest regulatory comparables to K973385.
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