PIT’Stop® implant

K170688 · In2bones Sas · HWC · Nov 28, 2017 · Orthopedic

Device Facts

• Record ID: K170688
• Device Name: PIT’Stop® implant
• Applicant: In2bones Sas
• Product Code: HWC · Orthopedic
• Decision Date: Nov 28, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The PIT Stop implant is indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela. - Flat foot treatment in children and adolescents - Congenital flat foot - Non successful long term orthopaedic treatment (shoes, insoles ... ) - Tarsal coalitions - Painfully flat foot - Supple deformity in posterior tibial tendon dysfunction - Paralytic flat foot - Subtalar instability

Device Story

Cannulated subtalar implant; PEEK construction with tantalum markers; 7 sizes (10mm-17mm). Implanted into sinus tarsi axis; anti-return flanges provide fixation. Blocks forward, downward, medial talar displacement; limits excessive pronation while maintaining normal subtalar motion. Intended for surgical use by orthopedic surgeons. Single-use; sterile (gamma irradiation). Requires removal post-growth (pediatric) or by 12 months (adult). Benefits include stabilization of hyperpronated foot and correction of flat foot deformities.

Clinical Evidence

Bench testing only. Static and dynamic compression tests performed by independent laboratory. No clinical or animal testing conducted.

Technological Characteristics

Cannulated implant; PEEK (ASTM F2026) with tantalum markers (ASTM F560). Anti-return flanges for fixation. 7 sizes (10mm-17mm). Sterile, gamma-irradiated, single-use.

Indications for Use

Indicated for children and adults with hyperpronated foot, congenital flat foot, tarsal coalitions, painful flat foot, posterior tibial tendon dysfunction, paralytic flat foot, or subtalar instability requiring subtalar joint stabilization.

Regulatory Classification

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Newdeal KALIX® II Flat foot implant (K061765)
• Solana Surgical, LLC, Gaitway Implant System (K122738)
• In2Bones OS2®-VP varisation staple (K153770)

Submission Summary (Full Text)

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November 28, 2017 In2bones Sas % Norman Estrin Managing Partner Estrin Consulting Group LLC 3100 N. Leisure World Blvd., Apt. 121 Silver Spring, Maryland 20906

Re: K170688

Trade/Device Name: PIT'Stop® implant Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: October 17, 2017 Received: October 23, 2017

Dear Norman Estrin:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Vincent J. Devlin -S for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K170688

#### Device Name

PIT'Stop® implant

Indications for Use (Describe)

The PIT Stop implant is indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela.

- Flat foot treatment in children and adolescents
- Congenital flat foot
- Non successful long term orthopaedic treatment (shoes, insoles ... )
- Tarsal coalitions
- Painfully flat foot
- Supple deformity in posterior tibial tendon dysfunction
- Paralytic flat foot
- Subtalar instability

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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# For

| Sponsor identification | In2Bones SAS<br>28 chemin du Petit Bois<br>69130 Ecully – France<br>Phone: [phone]<br>Fax: [phone] |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment<br>registration number | 3010470577 |
| Date of preparation | October 13th, 2017 |
| Contact person | Norman F. Estrin, Ph.D.<br>Estrin Consulting Group LLC<br>3100 N. Leisure World Blvd.<br>Silver Spring, MD 20906<br>Phone: [phone]<br>Email: [e-mail] |
| Authorized Agent in<br>the United States | Norman F. Estrin, Ph.D.<br>Estrin Consulting Group LLC<br>3100 N. Leisure World Blvd.<br>Silver Spring, MD 20906<br>Phone: [phone]<br>Email: [e-mail] |
| Proprietary Name | PIT'Stop® implant |
| Common name | Subtalar implant |
| Device classification<br>regulation | 21 CFR 888. 3040: Smooth or threaded metallic bone<br>fixation screw or fastener<br>Class II |
| Device Product<br>Code and Panel | HWC: screw, fixation, bone<br>87 orthopedics |
| Device Description | The PIT'Stop® implant is a cannulated implant composed of<br>two symmetrical and flattened sides, and small blades.<br>The PIT'Stop® implant is designed to adequately maintain<br>the filling of the sinus tarsi, and is made of PEEK, a material<br>recognized for its mechanical and radiolucent properties.<br>The PIT'Stop® implant is introduced into the axis of sinus<br>tarsi, and its fixation is performed by anti-return flanges.<br>The PIT'Stop implant should be removed:<br>at the end of the growth when used in pediatric patients or by 12 months when used in adult patients or if pain occurs earlier Sizes: The PIT'Stop® implant is designed in 7 sizes, from<br>10mm to 17mm.<br>Material: The PIT'Stop® implant is made of PEEK according<br>to standard ASTM F2026 and include markers made of<br>tantalum according to ASTM F560.<br>Single use: The PIT'Stop® implant is designed for single use<br>only.<br>Sterilization: The PIT'Stop® implant is supplied sterile, using<br>gamma irradiation. |
| Predicate Devices | Newdeal KALIX® II Flat foot implant (K061765)<br>Solana Surgical, LLC, Gaitway Implant System (K122738)<br>In2Bones OS2®-VP varisation staple (K153770) |
| Indications for use: | The PIT'Stop® implant is indicated for use in the treatment<br>of the hyperpronated foot and stabilization of the subtalar<br>joint.<br>It is designed to block forward, downward and medial<br>displacement of the talus, thus allowing normal subtalar joint<br>motion but blocking excessive pronation and the resulting<br>sequela.<br>- Flat foot treatment in children and adolescents<br>- Congenital flat foot<br>- Non successful long term orthopaedic treatment (shoes,<br>insoles...)<br>- Tarsal coalitions<br>- Painfully flat foot<br>- Supple deformity in posterior tibial tendon dysfunction<br>- Paralytic flat foot<br>- Subtalar instability |

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| Comparison of the<br>indications for use<br>with the predicate<br>device: | The indications for use for the PIT'Stop® implant are identical to<br>the predicate devices Newdeal KALIX® II Flat foot implant<br>(K061765), and Solana Surgical, LLC, Gaitway Implant System<br>(K122738). |
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| Comparison of<br>Technological<br>characteristics and<br>Substantial<br>Equivalence<br>Summary: | The PIT'Stop® implant is similar to the predicate devices Newdeal<br>KALIX® II Flat foot implant (K061765) and Solana Surgical, LLC,<br>Gaitway Implant System (K122738) in intended use, design, sizes<br>and principles of operation, and is similar to the predicate device<br>OS2®-VP Varisation staple (K153770) in material. |
| Summary<br>Performance Data | Performance testing of the PIT'Stop® implant was assessed through<br>mechanical bench testing performed by an independent test<br>laboratory, animal and clinical testing being considered not<br>applicable.<br>Testing performed included static and dynamic compression tests<br>on PIT'Stop® implant. The results of the testing performed by the<br>independent test laboratory indicate that the PIT'Stop® implant met<br>the acceptance criteria. |
| CONCLUSION | Based on the comparison of indications for use and technological<br>characteristics and the results of the testing performed, the<br>PIT'Stop® implant is substantially equivalent to the predicate<br>devices identified in the 510(k) submission. |