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PIT’Stop® implant

by In2Bones SAS

510(k) K170688

Active European Union and United States

CE MDR CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 26 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K170688↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 26 Oct 2026.

Regulatory status

as of registry sync 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK170688 Date28 Nov 2017ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K170688 decided 28 Nov 2017 Active
  • EUDAMED Active· +1 more in the status table

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR, CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA product code
HWC
Device class
Class II
Regulation
21 CFR Part 888.3040
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The PITStop Implant is a surgical device classified under the orthopedic category, designed to address peri-implant tibial tunnel enlargement (PITTE) in anterior cruciate ligament (ACL) reconstruction procedures. Constructed as a rigid fixation device, it stabilizes the tibial tunnel during bone healing to prevent widening and ensure proper integration of the graft.

This implant is supplied sterile and intended for single-use in orthopedic settings. It is manufactured under FDA 510(k) clearance (K170688) and complies with the Medical Device Directive (MDD) and Medical Device Regulation (MDR). The device is available in a standardized form without additional sizing specifications, and its use requires adherence to sterile surgical protocols. No MRI safety information is provided in the specifications.

Devices cleared under K170688

7 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K170688
UDI-DISize and differences
PIT'STOP® M20 SP010
In2Bones, USA
M20 SP010 / M20 SP01003760225713334
Length 12.7 mm; Width 10 mm
On the market
PIT'STOP® M20 SP011
In2Bones, USA
M20 SP011 / M20 SP01103760225713341
Width 11 mm; Length 13.3 mm
On the market
PIT'STOP® M20 SP012
In2Bones, USA
M20 SP012 / M20 SP01203760225713358
Length 14.4 mm; Width 12 mm
On the market
PIT'STOP® M20 SP013
In2Bones, USA
M20 SP013 / M20 SP01303760225713365
Width 13 mm; Length 14.9 mm
On the market
PIT'STOP® M20 SP014
In2Bones, USA
M20 SP014 / M20 SP01403760225713372
Length 15.9 mm; Width 14 mm
On the market
PIT'STOP® M20 SP015
In2Bones, USA
M20 SP015 / M20 SP01503760225713389
Width 15 mm; Length 16.4 mm
On the market
PIT'STOP® M20 SP017
In2Bones, USA
M20 SP017 / M20 SP01703760225713396
Length 18 mm; Width 17 mm
On the market

Similar devices

Other devices filed under FDA product code HWC (Screw, Fixation, Bone).

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