Cleared Traditional

K991037 - EUCLID REDUCTION AND GUIDANCE SYSTEM

K991037 is an FDA 510(k) clearance for EUCLID REDUCTION AND GUIDANCE SYSTEM, manufactured by Modular Cutting Systems, Inc.. The device is a Class 2 Orthopedic device with product code JDS cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K991037 · Modular Cutting Systems, Inc. · Orthopedic device
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Jun 1999
Decision
86d
Days
Class 2
Risk

K991037 is an FDA 510(k) clearance for the EUCLID REDUCTION AND GUIDANCE SYSTEM. Classified as Nail, Fixation, Bone (product code JDS), Class II - Special Controls.

Submitted by Modular Cutting Systems, Inc. (Bridgeport, US). The FDA issued a Cleared decision on June 23, 1999 after a review of 86 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.

View all Modular Cutting Systems, Inc. devices

FDA 510(k) Submission Details - K991037

510(k) Number K991037 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 1999
Decision Date June 23, 1999
Days to Decision 86 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
36d faster than avg
Panel avg: 122d · This submission: 86d
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 40
Devices cleared under the same product code (JDS) and FDA review panel - the closest regulatory comparables to K991037.
ALTA FULLY THREADED CROSS-LOCKING 5.0 MM SCREW
K993004 · Howmedica Osteonics Corp. · Oct 1999
SYNTHES SPIRAL BLADE FOR HUMERAL NAIL (SBHN)
K992348 · Synthes (Usa) · Sep 1999
MACMED PAEDIATRIC INTRAMEDULLARY NAIL
K991877 · Innervision, Inc. · Aug 1999
INTRAMEDULLARY NAIL SYSTEM, LOCKING SCREW, NAIL CAP
K983942 · Smith & Nephew, Inc. · Dec 1998
TITANIUM INTRAMEDULLARY NAIL, TITANIUM LOCKING SCREW
K981529 · Smith & Nephew, Inc. · Jul 1998
SYNTHES (USA) FLEXIBLE HUMERAL NAIL(FLEX NAIL) SYSTEM
K972516 · Synthes (Usa) · Sep 1997