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
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 Peers - HWC Screw, Fixation, Bone

All 691
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
Large Screws Range
K172596 · Newclip Technics · Oct 2017
BePOD® Foot Screws
K163148 · Fournitures Hospitalieres Industrie · Sep 2017