Cleared Traditional

Fiji Anchor (K171228) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence.

K171228 · Sportwelding GmbH · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2018
Decision
268d
Days
Class 2
Risk

K171228 is an FDA 510(k) clearance for the Fiji Anchor. Classified as Fastener, Fixation, Biodegradable, Soft Tissue (product code MAI), Class II - Special Controls.

Submitted by Sportwelding GmbH (Schlieren, CH). The FDA issued a Cleared decision on January 19, 2018 after a review of 268 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 Sportwelding GmbH devices

Submission Details

510(k) Number K171228 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 2017
Decision Date January 19, 2018
Days to Decision 268 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
146d slower than avg
Panel avg: 122d · This submission: 268d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MAI Fastener, Fixation, Biodegradable, Soft Tissue
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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Orthopedic devices follow this clearance model.

Regulatory Consultant

Hogan Lovells US LLP
Janice M. Hogan

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.

Clinical Evidence

ClinicalTrials.gov
NCT02042846 Unknown Interventional Industry-sponsored

Clinical Evaluation of the SportWelding FijiAnchor® in Hand and Hand Wrist Surgery

Prospective Clinical Evaluation of the Bioabsorbable SportWelding FijiAnchor® for Ligament Repair of the Hand and Hand Wrist

30
Patients (est.)
1
Site
Treatment
Purpose
Open label
Masking
Condition studied Lesion of Ligament of Wrist and/or Hand
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator Rohit Arora, MD
Sponsor SportWelding GmbH (industry)
Started 2014-01-01 → Primary completion 2016-06-01
Primary outcome
Operation success
Secondary outcome
Clinical function
View full study on ClinicalTrials.gov

Regulatory Peers - MAI Fastener, Fixation, Biodegradable, Soft Tissue

All 219
Devices cleared under the same product code (MAI) and FDA review panel - the closest regulatory comparables to K171228.
Arthrex Bioabsorbable PushLock Suture Anchors
K253931 · Arthrex, Inc. · May 2026
SF Push-in Anchor
K260294 · Surgical Fusion Technologies GmbH · Mar 2026
OSSIOfiber® Suture Anchor
K254055 · OSSIO , Ltd. · Feb 2026
Biosteon® Screw
K251680 · Biocomposites, Ltd. · Feb 2026
BioBrace® Extra-Articular Ligament Augmentation Kit
K252946 · Conmed Corporation · Oct 2025
OSSIOfiber® Interference Screw
K252022 · OSSIO , Ltd. · Aug 2025