Cleared Traditional

K884407 - TRACER SKELETAL TRACTION PINS

K884407 is an FDA 510(k) clearance for TRACER SKELETAL TRACTION PINS, manufactured by De Medica Mfg., Inc.. The device is a Class 2 Orthopedic device with product code HSB cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K884407 · De Medica Mfg., Inc. · Orthopedic device
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Nov 1988
Decision
40d
Days
Class 2
Risk

K884407 is an FDA 510(k) clearance for the TRACER SKELETAL TRACTION PINS. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), 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 888.3020 - 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.

FDA 510(k) Submission Details - K884407

510(k) Number K884407 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.

HSB Device Classification - Class 2, Special Controls

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 522
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K884407.
ALTA HOLLOW TIBIAL RODS
K890936 · Howmedica Corp. · Jun 1989
ALTA NON-REAMED TIBIAL ROD
K884500 · Howmedica Corp. · Jan 1989
INTERLOCKING INTRAMEDULLARY NAILS
K884610 · Depuy, Inc. · Dec 1988
ZINDRICK IM ROD INSTRUMENTS
K882443 · Buckman Co., Inc. · Jun 1988
ZINDRICK IM ROD
K871539 · Buckman Co., Inc. · Aug 1987
MODIFIED HUCKSTEP INTRAMEDULLARY NAIL
K871947 · Downs Surgical , Ltd. · Aug 1987
K884407 · TRACER SKELETAL TRACTION PINS
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