Cleared Traditional

K261057 - ActivaScrew™ Cannulated COM

K261057 is an FDA 510(k) clearance for ActivaScrew Cannulated COM, manufactured by Bioretec, Ltd.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 157-day FDA review.

K261057 · Bioretec, Ltd. · Orthopedic device
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Sep 2026
Decision
157d
Days
Class 2
Risk

K261057 is an FDA 510(k) clearance for the ActivaScrew™ Cannulated COM. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Bioretec, Ltd. (Tampere, FI). The FDA issued a Cleared decision on September 4, 2026 after a review of 157 days - an extended review 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: 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 Bioretec, Ltd. devices

FDA 510(k) Submission Details - K261057

510(k) Number K261057 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2026
Decision Date September 04, 2026
Days to Decision 157 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 slower than avg
Panel avg: 122d · This submission: 157d
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

Compliance Solutions (Life Sciences) , Ltd.
Mari Ruotsalainen

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 1016
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K261057.
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K253858 · T.A.G. Medical Products Corporation, Ltd. · Aug 2026