Cleared Traditional

EXPERT - Joint Fixation System (K200332) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K200332 · GM Dos Reis Industria e Comercio Ltda. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2020
Decision
262d
Days
Class 2
Risk

K200332 is an FDA 510(k) clearance for the EXPERT - Joint Fixation System. Classified as Washer, Bolt Nut (product code HTN), Class II - Special Controls.

Submitted by GM Dos Reis Industria e Comercio Ltda. (Campinas, BR). The FDA issued a Cleared decision on October 29, 2020 after a review of 262 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all GM Dos Reis Industria e Comercio Ltda. devices

Submission Details

510(k) Number K200332 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 2020
Decision Date October 29, 2020
Days to Decision 262 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
140d slower than avg
Panel avg: 122d · This submission: 262d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HTN Washer, Bolt Nut
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 Consultant

Pr Servicos Regulatorios Administrativos Ltda
Graziela Brum

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HTN Washer, Bolt Nut

All 91
Devices cleared under the same product code (HTN) and FDA review panel - the closest regulatory comparables to K200332.
SportLinc Syndesmosis Device
K252081 · Lincotek Medical · Mar 2026
Syndesmosis TightRope PRO
K253727 · Arthrex, Inc. · Dec 2025
Synchfix EVT
K251643 · Wright Medical Technology, Inc. (Stryker Corporation) · Oct 2025
RipCord
K251134 · TriMed, Inc. · Jul 2025
Acu-Sinch Knotless Mini
K243624 · Acumed, LLC · Jan 2025
Bolo Button System
K242091 · Fusion Orthopedics · Dec 2024