Cleared Traditional

K163489 - OrthoSolutions 'System26' Bone Screws

K163489 is an FDA 510(k) clearance for OrthoSolutions 'System26' Bone Screws, manufactured by Ortho Solutions UK Limited. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K163489 · Ortho Solutions UK Limited · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2017
Decision
86d
Days
Class 2
Risk

K163489 is an FDA 510(k) clearance for the OrthoSolutions 'System26' Bone Screws. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Ortho Solutions UK Limited (Maldon, GB). The FDA issued a Cleared decision on March 8, 2017 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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.

FDA 510(k) Submission Details - K163489

510(k) Number K163489 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 2016
Decision Date March 08, 2017
Days to Decision 86 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
36d faster than avg
Panel avg: 122d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HWC Device Classification - Class 2, Special Controls

Product Code HWC Screw, Fixation, Bone
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 Consultant

Engineering Consulting Services, Inc.
Al Lippincott

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 - HWC Screw, Fixation, Bone

All 1056
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K163489.
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K163489 · OrthoSolutions 'System26' Bone Screws
Download PDF FDA Summary Ortho Solutions UK Li…