Cleared Traditional

K033115 - ORTHODEK

K033115 is the FDA 510(k) clearance for ORTHODEK by Teleflex Medical. It is a Class 2 General & Plastic Surgery device (product code GAM) cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K033115 · Teleflex Medical · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2003
Decision
48d
Days
Class 2
Risk

K033115 is an FDA 510(k) clearance for the ORTHODEK. Classified as Suture, Absorbable, Synthetic, Polyglycolic Acid (product code GAM), Class II - Special Controls.

Submitted by Teleflex Medical (Fall River, US). The FDA issued a Cleared decision on November 17, 2003 after a review of 48 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4493 - the FDA general and plastic surgery device 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 Teleflex Medical devices

Submission Details

510(k) Number K033115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2003
Decision Date November 17, 2003
Days to Decision 48 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 115d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4493
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GAM Suture, Absorbable, Synthetic, Polyglycolic Acid

All 74
Devices cleared under the same product code (GAM) and FDA review panel - the closest regulatory comparables to K033115.
PASSING NEEDLE WITH ETHIBOND, PANACRYL OR ORTHOCORD SUTURE
K041806 · Depuy Mitek, A Johnson & Johnson Company · Aug 2004
MODIFIED COATED VICRYL* RAPIDE (POLYGLACTIN 910) SUTURE
K033746 · Ethicon, Inc. · Dec 2003
CAPROSYN ABSORBABLE SUTURE
K032586 · United States Surgical, A Division of Tyco Healthc · Nov 2003
MODIFIED COATED VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SYNTHETIC ABSORBABLE SUTURE
K032420 · Ethicon, Inc. · Oct 2003
SAFIL AND SAFIL QUICK SYNTHETIC ABSORBABLE SURGICAL SUTURE
K031286 · Aesculap, Inc. · May 2003
COATED VICRYL PLUS ANTIMICROBIAL (POLYGLACTIN 910) SUTURE
K022715 · Ethicon, Inc. · Dec 2002