The RECON system consists of various system components and it is indicated for the treatment of fracture fixation, non-unions, joint decompression and fusion, osteotomies, reconstruction or arthrodeses of bones. The system can be used in both adult and pediatric patients.

Device Description

The RECON system – V-TEK-IVP Plates and Screws is a plate and screw system intended for internal fixation. The system consists of the following plates and screws:

V-TEK™ IVP Micro XS Plate 2.7, ●
V-TEK™ IVP S Plate 2.7, .
V-TEK™ IVP S. L-Plate 2.7 .
. V-TEK™ IVP M Plate 2.7
V-TEK™ IVP M Plate 3.5 .
. V-TEK™ IVP L Plate 2.7
V-TEK™ IVP L Plate 2.7 / 3.5
. Titanium Screw Fully Treaded 2.7/3.5

of different sizes and designs.

The plates and screws are made of titanium alloy Ti-6AI-4V (ASTM F136).

The implants are offered in various sizes to accommodate the variations of bone size and geometry. The implants are provided non-sterile and single-use only. The instruments are non-sterile and reusable or for single use.

AI/ML Overview

This document is a 510(k) premarket notification for the RECON system - V-TEK-IVP Plates and Screws. It describes the device and its intended use, and argues for its substantial equivalence to several predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly define "acceptance criteria" in a quantitative, pass/fail sense for device performance. Instead, it relies on comparison to predicate devices and established standards. The reported device "performance" is primarily described as having "similar mechanical properties and performance" to the predicate devices.

Metric/Characteristic	Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility	Compliance with ISO 10993-1	All testing passed.
Mechanical Properties:
Cross-sectional engineering analysis (plates)	Similar to predicate devices (K010321, K063303, K060710, K143066)	Resulted in similar mechanical properties and performance.
Proof load (plates)	Similar to predicate devices (K010321, K063303, K060710, K143066)	Resulted in similar mechanical properties and performance.
Bending strength (plates)	Similar to predicate devices (K010321, K063303, K060710, K143066)	Resulted in similar mechanical properties and performance.
Bending stiffness (plates)	Similar to predicate devices (K010321, K063303, K060710, K143066)	Resulted in similar mechanical properties and performance.
Equivalent bending stiffness (plates)	Similar to predicate devices (K010321, K063303, K060710, K143066)	Resulted in similar mechanical properties and performance.
Fatigue strength (plates)	Similar to predicate devices (K010321, K063303, K060710, K143066)	Resulted in similar mechanical properties and performance.
Self-tapping performance (screws)	Similar to predicate devices (K063303, K060710, K143165)	Resulted in similar mechanical properties and performance.
Driving and removal torque (screws)	Similar to predicate devices (K063303, K060710, K143165)	Resulted in similar mechanical properties and performance.
Torque to failure (screws)	Similar to predicate devices (K063303, K060710, K143165)	Resulted in similar mechanical properties and performance.
Axial pullout (screws)	Similar to predicate devices (K063303, K060710, K143165)	Resulted in similar mechanical properties and performance.
Intended Use	Same as predicate devices	The RECON system - V-TEK-IVP Plates and Screws have the same intended use.
Materials	Similar to predicate devices	Manufactured from similar materials (Titanium alloy Ti-6AI-4V (ASTM F136)).
Design	Similar to predicate devices	Similar in design to the predicate devices.

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

The document describes non-clinical performance data which includes biocompatibility and mechanical testing.

Sample Size: The document does not specify the exact sample sizes used for the mechanical testing or biocompatibility studies. It only states that testing was "conducted and evaluated."
Data Provenance: The data is from non-clinical laboratory testing performed on the devices themselves, not from human or animal subjects. Thus, there is no country of origin of data or retrospective/prospective classification in the clinical sense.

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

This document does not involve a study with a "test set" requiring expert ground truth establishment in the context of diagnostic or interpretive performance. The studies are engineering and biocompatibility tests of a physical medical device (bone plates and screws).

4. Adjudication Method for the Test Set:

Not applicable, as there is no "test set" requiring expert adjudication for ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is a submission for a physical orthopedic implant (bone plates and screws), not a diagnostic or AI-assisted device. Therefore, no MRMC study or AI performance evaluation was conducted or is relevant.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a physical medical device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

For the non-clinical performance data, the "ground truth" is based on:

Biocompatibility: Adherence to the Pass/Fail criteria defined within the ISO 10993-1 standard for biological evaluation of medical devices.
Mechanical Testing: Comparison of the measured mechanical properties (proof load, bending strength, fatigue strength, torque, pullout, etc.) of the subject device against those of the legally marketed predicate devices, with the aim of demonstrating "similar" performance. The implicit ground truth here is that the predicate devices have established safety and effectiveness.

8. The Sample Size for the Training Set:

Not applicable. This device does not involve machine learning or AI, and therefore has no "training set."

9. How the Ground Truth for the Training Set was Established:

Not applicable. There is no training set for this type of device submission.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus with three human profiles facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top and left side of the emblem in a circular fashion.

October 30, 2015

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

Normed Medizin-Technik GmbH Mr. Arne Briest RA/QA Manager Ulrichstrasse 7 D-78532 DE Tuttlingen Germany

Re: K152312

Trade/Device Name: RECON System - V-TEK-IVP Plates and Screws Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances and Accessories Regulatory Class: Class II Product Code: HRS. HWC Dated: August 14, 2015 Received: August 17, 2015

Dear Mr. Arne Briest:

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

{1}------------------------------------------------

Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Mark N. Melkerson -S

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

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K152312

page 1 of 1

Device Name

RECON system - V-TEK-IVP Plates and Screws

Indications for Use (Describe)

The implants are intended to support normal bone healing for osteotomies, fractures, non-unions and reconstructions.

The RECON system consists of various system components and it is indicated for the treatment of fracture fixation, nonunions, joint decompression and fusion, osteotomies, reconstruction or arthrodeses of bones. The system can be used in both adult and pediatric patients.

Additional information is provided in the corresponding surgical techniques.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/2 description: The image is a logo for NORMED, a Zimmer company. The logo is black and white, with the word "NORMED" in large, bold letters. The "O" in NORMED is replaced with a graphic of the earth. Below the word "NORMED" is the text "A ZIMMER COMPANY" in a smaller, blue font.

510(k) Summary

1. Submission Sponsor and Correspondent

Normed Medizin-Technik GmbH Ulrichstrasse 7 D-78532 Tuttlingen Germany

Phone:	+ 49 7461 93 43 0
Fax:	+ 49 7461 93 43 20
Contact:	Mr. Arne Briest

FDA Establishment Registration #:

2. Date Prepared

Date Prepared:

October 16, 2015

9611091

3. Device Identification

Trade/Proprietary Name: RECON system - V-TEK-IVP Plates and Screws Common/Usual Name: bone plate and screw Classification Name: Plate, Fixation, Bone Screw, Fixation, Bone Classification Regulation 21CFR 888.3030 21CFR 888.3040 HRS Product Code: HWC Device Class: Class II Classification Panel Orthopedic

{4}------------------------------------------------

Image /page/4/Picture/2 description: The image is a logo for NORMED, a Zimmer company. The text above the logo reads "The specialist for small bones". The logo itself is a stylized version of the word "NORMED", with the "O" replaced by a graphic of the earth.

4. Legally Marketed Predicate Device

K010321 - Modular Foot System - 2.7 mm Module, manufactured by Synthes Inc., cleared May 2, 2001

K063303 - Universal Locking Plate System 2.7, Plates and Screws, manufactured by Zimmer Inc., cleared November 22, 2006

K060710 - Universal Locking Plate System 3.5, Plates and Screws manufactured by Zimmer Inc., cleared April 26, 2006

K143066 - Zimmer Plates and Screws System (ZPS) - Non-sterile ZPS Plate Line Extensions, Sterile/Non-sterile ZPS Screws and Washers, manufactured by Zimmer Inc., cleared November 28, 2014

K143165 - Herbert/Whipple Bone Screw System, Herbert Bone Screw, Herbert Cannulated Bone Screw System, and Herbert Mini Bone Screw, manufactured by Zimmer Inc., cleared March 31, 2015

K120157 - Mini Max Lock Extreme Plating System, manufactured by OrthoHelix Designs Inc., cleared April 10, 2012

K151407 - Recon System, manufactured by Normed Medizin-Technik GmbH, cleared August 12, 2015

{5}------------------------------------------------

Image /page/5/Picture/2 description: The image is a logo for NORMED, a Zimmer company. The logo features the text "The specialist for small bones" above the word "NORMED" in a bold, stylized font. The "O" in NORMED is replaced by a circular graphic with a world map inside. Below the word "NORMED" is the text "A ZIMMER COMPANY" with a blue Z logo.

5. Device Description

The RECON system – V-TEK-IVP Plates and Screws is a plate and screw system intended for internal fixation. The system consists of the following plates and screws:

V-TEK™ IVP Micro XS Plate 2.7, ●
V-TEK™ IVP S Plate 2.7, .
V-TEK™ IVP S. L-Plate 2.7 .
. V-TEK™ IVP M Plate 2.7
V-TEK™ IVP M Plate 3.5 .
. V-TEK™ IVP L Plate 2.7
V-TEK™ IVP L Plate 2.7 / 3.5
. Titanium Screw Fully Treaded 2.7/3.5

of different sizes and designs.

The plates and screws are made of titanium alloy Ti-6AI-4V (ASTM F136).

{6}------------------------------------------------

Image /page/6/Picture/2 description: The image shows the logo for NORMED, a Zimmer company. The logo is black and white and features the word "NORMED" in a bold, sans-serif font. Above the word "NORMED" is the text "The specialist for small bones". Below the word "NORMED" is the text "A ZIMMER COMPANY".

6. Indications for Use

The implants are intended to support normal bone healing for osteotomies, fractures, non-unions and reconstructions.

Additional information is provided in the corresponding surqical techniques.

7. Substantial Equivalence Discussion

The RECON system - V-TEK-IVP Plates and Screws have the same intended use, similar performance characteristics, is manufactured from similar materials and is similar in design to the predicate devices.

8. Non-Clinical Performance Data

-Biocompatibility - Biocompatibility testing on the plates was conducted and evaluated per ISO 10993-1. All testing passed.
-Cross sectional engineering analysis of the plates, proof load, bending strength, bending stiffness, equivalent bending stiffness and fatique strength of the RECON System-V-TEK IVP and the predicate devices, the Modular Foot System - 2.7 mm Module (K010321), Zimmer Universal Locking System (ULS) Plates and Screws (K063303 and K060710), and Zimmer Plates and Screws System (ZPS) (K143066) resulted in similar mechanical properties and performance. The subject and predicate devices are substantially equivalent.
-Self-tapping performance, driving and removal torque, torque to failure and axial pullout of the RECON System - V-TEK IVP screws and the predicate devices, the Zimmer Universal Locking System (ULS) Plates and Screws (K063303 and K060710) and Herbert/Whipple Bone Screw System, Herbert Bone Screw, Herbert Cannulated Bone Screw System, and Herbert Mini Bone Screw (K143165), resulted in similar mechanical properties and performance. The subject and predicate devices are substantially equivalent.

9. Clinical Performance Data

There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. These types of devices, including the predicate devices, have been on the market for many years with a proven safety and efficacy for the use of the device.

{7}------------------------------------------------

Image /page/7/Picture/2 description: The image is a logo for NORMED, a Zimmer company. The logo is black and white and features the word "NORMED" in large, bold letters. Above the word "NORMED" is the text "The specialist for small bones". Below the word "NORMED" is the text "A ZIMMER COMPANY".

10. Statement of Substantial Equivalence

By definition, a device is substantially equivalent to a predicate device has the same intended use and the same technological characteristics as the previously cleared predicate device. Or the device has the same intended use and different technological characteristics that can be demonstrated that the device is substantially equivalent to the predicate device, and that the new device does not raise different questions regarding its safety and effectiveness as compared to the predicate device.

It has been shown in this 510(k) submission that the difference between the RECON system -V-TEK-IVP Plates and Screws and the predicate devices do not raise any questions regarding its safety and effectiveness.

Performance testing and compliance with voluntary standards, demonstrate that the RECON system - V-TEK-IVP Plates and Screws are substantially equivalent to the relevant aspects of the predicate devices in terms of design, components, materials, principals of operation, biocompatibility, performance characteristics, and intended use.

The RECON system - V-TEK-IVP Plates and Screws are determined to be substantially equivalent to the referenced predicate devices.

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.