Cleared Traditional

K170688 - PIT’Stop® implant

K170688 is an FDA 510(k) clearance for PIT’Stop implant, manufactured by In2bones Sas. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K170688 · In2bones Sas · Orthopedic device
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Nov 2017
Decision
266d
Days
Class 2
Risk

K170688 is an FDA 510(k) clearance for the PIT’Stop® implant. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by In2bones Sas (Ecully, FR). The FDA issued a Cleared decision on November 28, 2017 after a review of 266 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 In2bones Sas devices

FDA 510(k) Submission Details - K170688

510(k) Number K170688 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 2017
Decision Date November 28, 2017
Days to Decision 266 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
144d slower than avg
Panel avg: 122d · This submission: 266d
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

Estrin Consulting Group,Llc
Norman F. Estrin

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 1019
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K170688.
HBS2 Headless Bone Screw
K171628 · Stuckenbrock Medizintechnik GmbH · Jan 2018
Arthrosurface Bone Screws
K172383 · Arthrosurface, Inc. · Dec 2017
Cannulated Screw Internal Fixation System
K173286 · Life Spine, Inc. · Dec 2017
VariAx 2 System
K173135 · Stryker GmbH · Nov 2017
Treace Medical Concepts (TMC) Compression Screw System
K172617 · Treace Medical Concepts, Inc. · Oct 2017
IRENE Cannulated Screw System
K170056 · Tianjin Zhengtian Medical Instrument Co., Ltd. · Oct 2017