Cleared Traditional

K102777 - TWISTCUT ENDOSORB SCREWS

K102777 is an FDA 510(k) clearance for TWISTCUT ENDOSORB SCREWS, manufactured by Merete Medical GmbH. The device is a Class 2 Orthopedic device with product code JDW cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K102777 · Merete Medical GmbH · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2010
Decision
87d
Days
Class 2
Risk

K102777 is an FDA 510(k) clearance for the TWISTCUT ENDOSORB SCREWS. Classified as Pin, Fixation, Threaded (product code JDW), Class II - Special Controls.

Submitted by Merete Medical GmbH (Berlin, DE). The FDA issued a Cleared decision on December 20, 2010 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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 Merete Medical GmbH devices

FDA 510(k) Submission Details - K102777

510(k) Number K102777 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2010
Decision Date December 20, 2010
Days to Decision 87 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 122d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDW Device Classification - Class 2, Special Controls

Product Code JDW Pin, Fixation, Threaded
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - JDW Pin, Fixation, Threaded

All 59
Devices cleared under the same product code (JDW) and FDA review panel - the closest regulatory comparables to K102777.
BIOPRO KWICK-WIRE UNIVERSAL SCREW SYSTEM
K130298 · Biopro, Inc. · Jun 2013
SMITH & NEPHEW, INC. EXTERNAL FIXATION SYSTEM INSTRUMENTATION
K120871 · Smith & Nephew, Inc. · Jun 2012
ROCKWOOD CLAVICLE PINS
K103001 · DePuy Orthopaedics, Inc. · Feb 2011
PROTOE ENDOSORB SMALL HAMMER TOE PIN
K100414 · Merete Medical GmbH · Jul 2010
ACUMED CLAVICLE SCREW SYSTEM
K083144 · Acumed, LLC · Jun 2009
ALLOFIX ANCHOR, 5.0 MM ANCHOR
K061498 · Musculoskeletal Transplant Foundation · Jul 2006