The OsteoSpring FootJack™ Subtalar Implant System is indicated for use in the treatment of hyperpronated foot and stabilization of the subtalar joint. It is designed to block the anterior and inferior displacement of the talus, thus allowing normal subtalar joint motion but limited excessive pronation and resulting sequela. The OsteoSpring FootJack Implant System . implants are intended for single patient use only.

Device Description

The OsteoSpring FootJack™ subtalar implant is intended to be implanted into the sinus tarsi of the foot. It will be available in a range of sizes. The implant is a solid, one-piece, conical, thread shaped and cannulated design.

AI/ML Overview

Acceptance Criteria and Study for the OsteoSpring FootJack™ Subtalar Implant System

Based on the provided 510(k) summary (K112658), the OsteoSpring FootJack™ Subtalar Implant System did not undergo clinical studies to prove its acceptance criteria. Instead, it relied on non-clinical testing and claims of substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Mechanical Safety/Integrity	Withstand load testing without functional failure or defect.	"The results of this testing indicate that the OsteoSpring FootJack™ Implant met the acceptance criteria and withstood the load testing without functional failure or defect."
Substantial Equivalence	Equivalent in terms of intended use, design, materials used, mechanical safety, and performances to predicate devices (OsteoMed Subtalar Implant System - K031155, Instratek Subtalar Lok™ - K080280, BioArch™ Subtalar Implant - K070441).	"The OsteoSpring FootJack™ subtalar implant is substantially equivalent to the OsteoMed Subtalar Implant System, Instratek Subtalar Lok™ and BioArch™ Subtalar Implant in terms of intended use, design, materials used, mechanical safety and performances." "The OsteoSpring FootJack™ Subtalar Implant System is substantially equivalent to the predicate devices in terms of indications for use, design, material, performance and function."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not applicable. No clinical test set involving patient data was used. The testing was non-clinical.
Data Provenance: Not applicable. The data comes from in-vitro (Finite Element Analysis and Static Compression Testing) studies, not from human subjects or clinical settings, hence no country of origin or retrospective/prospective classification applies.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. The non-clinical tests (Finite Element Analysis and Static Compression Testing) assess physical and mechanical properties, not interpretations of clinical data that would require expert consensus.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set requiring adjudication was performed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is an implant, not an AI or imaging diagnostic tool that would typically involve human readers.

6. Standalone Performance Study (Algorithm Only)

Not applicable. This device is a physical implant, not an algorithm. Therefore, "standalone performance" in the context of an algorithm does not apply.

7. Type of Ground Truth Used

For the mechanical performance, the "ground truth" was established by the physical and engineering properties of the device as measured by the static compression testing and simulated by the Finite Element Analysis. For the claim of substantial equivalence, the "ground truth" was the characteristics and performance data of the identified predicate devices against which the new device was compared.

8. Sample Size for the Training Set

Not applicable. This device did not involve any machine learning algorithms or AI that would require a training set.

9. How Ground Truth for the Training Set Was Established

Not applicable. As there was no training set for an algorithm, no ground truth needed to be established for it.

Summary

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112658

510(k) Summary for the OsteoSpring FootJack™ Subtalar Implant System

In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the OsteoSpring FootJack™ Subtalar Implant System.

GENERAL INFORMATION 1.

Date Prepared:	September 7, 2011
Trade Name:	OsteoSpring FootJack™ Subtalar Implant System
Common Name:	Subtalar implant
Classification Name:	Screw, fixation, bone
Class:	II
Product Code:	HWC
CFR section:	21 CFR section 888.3040
Device panel:	Orthopedic
Legally Marketed	OsteoMed Subtalar Implant System - K031155
Predicate Devices:	Instratek Subtalar Lok™ - K080280BioArch™ Subtalar Implant - K070441
Submitter:	OsteoSpring Medical Inc.228 Hamilton Avenue, 3rd FloorPalo Alto, CA 94301650-798-5284 Office
Contact:	J.D. Webb1001 Oakwood BlvdRound Rock, TX 78681512-388-0199E-Mail: ortho.medix@sbcglobal.net

2. DEVICE DESCRIPTION

Materials:

Titanium Alloy ELI per ASTM F136.

Function:

The conical threaded design of the FootJack implant is designed to block the anterior and inferior displacement of the talus, thus allowing normal subtalar joint motion but limiting excessive pronation and resulting sequela.

SUBSTANTIAL EQUIVALENCE CLAIMED TO PREDICATE DEVICES 3.

The OsteoSpring FootJack™ subtalar implant is substantially equivalent to the OsteoMed Subtalar Implant System, Instratek Subtalar Lok™ and BioArch™ Subtalar Implant in terms of intended use, design, materials used, mechanical safety and performances.

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4. INTENDED USE

The OsteoSpring FootJack™ Subtalar Implant System is in the treatment of hyperpronated foot and stabilization of the subtalar joint. It is designed to block the anterior and inferior displacement of the talus, thus allowing normal subtalar joint motion but limited excessive pronation and resulting sequela. The OsteoSpring FootJack Implant System implants are intended for single patient use only.

NON-CLINICAL TEST SUMMARY 5.

The following tests were conducted:

Finite Element Analysis .
. Static compression testing

The results of this testing indicate that the OsteoSpring FootJack™ Implant met the acceptance criteria and withstood the load testing without functional failure or defect.

6. CLINICAL TEST SUMMARY

No clinical studies were performed.

CONCLUSIONS NONCLINICAL AND CLINICAL 7.

The OsteoSpring FootJack™ Subtalar Implant System is substantially equivalent to the predicate devices in terms of indications for use, design, material, performance and function.

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Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

OsteoSpring Medical, Inc. % The OrthoMedix Group, Inc. % Mr. J.D. Webb 1001 Oakwood Boulevard Round Rock. Texas 78681

DEC 1 2 2011

Re: K112658

Trade/Device Name: OsteoSpring FootJack Subtalar Implant System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: I-IWC Dated: September 7, 2011 Received: September 13, 2011

Dear Mr. Webb:

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

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Page 2 – Mr. J.D. Webb

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

For Pat the
Denise

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K | |2 6 5 8

OsteoSpring FootJack™ Subtalar Implant System_ Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

Prescription Use ___X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Richard Owens to MXM

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K112658

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
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.(b)
Classification. Class II.