Cleared Traditional

K884406 - TRACER HIP PINNING SYSTEM

K884406 is an FDA 510(k) clearance for TRACER HIP PINNING SYSTEM, manufactured by De Medica Mfg., Inc.. The device is a Class 2 Orthopedic device with product code JDS cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K884406 · De Medica Mfg., Inc. · Orthopedic device
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Nov 1988
Decision
40d
Days
Class 2
Risk

K884406 is an FDA 510(k) clearance for the TRACER HIP PINNING SYSTEM. Classified as Nail, Fixation, Bone (product code JDS), Class II - Special Controls.

Submitted by De Medica Mfg., Inc. (Santa Paula, US). The FDA issued a Cleared decision on November 28, 1988 after a review of 40 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K884406

510(k) Number K884406 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1988
Decision Date November 28, 1988
Days to Decision 40 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 122d · This submission: 40d
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 51
Devices cleared under the same product code (JDS) and FDA review panel - the closest regulatory comparables to K884406.
UNIVERSAL FEMORAL NAIL
K914371 · Synthes (Usa) · Feb 1992
UNIVERSAL TIBIAL NAIL AND UNREAMED TIBIAL NAIL
K914453 · Synthes (Usa) · Feb 1992
HUMERAL LOCKING NAIL SYSTEM
K883882 · Howmedica Corp. · Jan 1989
INTRAMEDULLARY BONE PLUG
K832328 · Kirschner Medical Corp. · Oct 1983
SILASTIC BONE PLUG H.P.(CEMENT RESTRICT)
K800898 · Dow Corning Corp. Healthcare Industries Materials · May 1980
FUSON BONE PLUG, RADIOPAQUE
K800142 · Zimmer, Inc. · Feb 1980
K884406 · TRACER HIP PINNING SYSTEM
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