Cleared Traditional

K864515 - RING UPM TOTAL HIP REPLACEMENT

K864515 is an FDA 510(k) clearance for RING UPM TOTAL HIP REPLACEMENT, manufactured by Downs Surgical , Ltd.. The device is a Class 3 Orthopedic device with product code KWA cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K864515 · Downs Surgical , Ltd. · Orthopedic device
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Mar 1987
Decision
116d
Days
Class 3
Risk

K864515 is an FDA 510(k) clearance for the RING UPM TOTAL HIP REPLACEMENT. Classified as Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component) (product code KWA), Class III - Premarket Approval.

Submitted by Downs Surgical , Ltd. (Mitcham Surrey, GB). The FDA issued a Cleared decision on March 13, 1987 after a review of 116 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3330 - 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. High regulatory complexity profile. 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 Downs Surgical , Ltd. devices

FDA 510(k) Submission Details - K864515

510(k) Number K864515 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1986
Decision Date March 13, 1987
Days to Decision 116 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 122d · This submission: 116d
Pathway characteristics
Predicate-based equivalence.

KWA Device Classification - Class 3, Premarket Approval

Product Code KWA Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component)
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 888.3330
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.

Regulatory Peers - KWA Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component)

All 92
Devices cleared under the same product code (KWA) and FDA review panel - the closest regulatory comparables to K864515.
ATH METAL:UHMWPE TOTAL HIP SYSTEM
K882675 · Kinamed, Inc. · Aug 1988
OMNIFLEX NORMALIZED HIP STEM FOR PRESS-FIT FIXAT.
K872768 · Osteonics Corp. · Jan 1988
MODULAR RANGE OF RING PROS. FOR HIP REPLACEMENT
K871956 · Downs Surgical , Ltd. · Jun 1987
(MODIFIED) OMNIFIT THREADED ACETABULAR COMPONENT
K861723 · Osteonics Corp. · Jun 1986
KIRSCHNER SELF-TAPPING ACETABULAR CUP
K852351 · Kirschner Medical Corp. · Aug 1985
HOWMEDICA THREADED ACETABULAR COMPONENT
K850840 · Pfizer, Inc. · Jul 1985