(78 days)
No
The summary describes a traditional plate and screw system for fracture fixation and reconstruction, with no mention of AI or ML capabilities. The performance studies focus on mechanical properties and biocompatibility, not algorithmic performance.
No.
The device is described as a plate and screw system intended for internal fracture fixation and bone healing, which are typically considered supportive or restorative functions rather than therapeutic.
No
Explanation: The device described is a plate and screw system intended for internal fracture fixation, joint decompression and fusion, reconstruction or arthrodesis of small bones. It is an implantable medical device used for treatment, not for diagnosis.
No
The device description clearly states that the RECON system is a "plate and screw system intended for internal fracture fixation" and lists various physical components made of titanium alloy. This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the implants are for supporting bone healing for osteotomies, fractures, and reconstructions, and for the treatment of fracture fixation, joint decompression and fusion, reconstruction or arthrodeses of small bones. This is a therapeutic and structural purpose, not a diagnostic one.
- Device Description: The device is described as a plate and screw system for internal fracture fixation. This is a physical implant used within the body.
- Lack of Diagnostic Elements: There is no mention of the device being used to test samples from the human body (like blood, urine, tissue, etc.) or to provide information about a person's health status or disease.
IVD devices are used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used in vivo (inside the body) for structural support and fixation.
N/A
Intended Use / Indications for Use
The implants are intended to support normal bone healing for osteotomies, fractures, and reconstructions.
The RECON system consists of various system components and it is indicated for the treatment of fracture fixation, joint decompression and fusion, reconstruction or arthrodeses of small bones. The system can be used in both adult and pediatric patients. Additional information is provided in the corresponding surgical techniques.
Product codes
HRS, HWC, HTN
Device Description
The RECON system is a plate and screw system intended for internal fracture fixation. The system consists of the following plates:
- Reconstruction Plates 3.5, ●
- Medialis Plates 3.5, ●
- Universal Plates 3.5
- Universal Plates 3.5, H-shaped .
- USG Plates 3.5 ●
- Interpositioning Arthrodesis Plates ●
- Lapidus Plates ●
- . Dwyer Plates
screws and washers of different sizes and designs.
The plates, screws, and washers are either made of titanium alloy Ti-6AI-4V (ASTM F136) or commercially pure Titanium (C.P. Titanium; ASTM F67).
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Small bones
Indicated Patient Age Range
Adult and pediatric patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Biocompatibility testing on the plates, screws, and washer material 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 fatigue strength of the RECON System -plates and the predicate devices, the Zimmer Universal Locking System (ULS) Plates and Screws (K063303 and K060710) , resulted in similar mechanical properties and performance. The subject and predicate devices are substantially equivalent.
- Self-tapping performance, driving and removal torque, to failure and axial pullout of the RECON System -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.
- The subject washers are substantially equivalent to the washers cleared in K143066
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K143165, K063303, K060710, K022325, K022231, K143066, K090675, K121651, K141784, K111678
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
August 12, 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: K151407 Trade/Device Name: RECON System 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, HTN Dated: June 16, 2015 Received: June 18, 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
1
Page 2 - Mr. Arne Briest
(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 (OS) 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" (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 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
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | |
|---|---|
| Food and Drug Administration |
Indications for Use
510(k) Number (if known)
page 1 of 1
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017
See PRA Statement below.
Device Name RECON system
Indications for Use (Describe)
The implants are intended to support normal bone healing for osteotomies, fractures, and reconstructions.
The RECON system consists of various system components and it is indicated for the treatment of fracture fixation, joint decompression and fusion, reconstruction or arthrodeses of small 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)
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 features the text "NORMED" in a bold, sans-serif font, with a globe graphic incorporated into the letter "O". Above the text is the tagline "The specialist for small bones". Below the text is the text "A ZIMMER COMPANY" with a stylized Z to the left.
510(k) Summary
9611091
Submission Sponsor and Correspondent 1.
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: July 22, 2015
3. Device Identification
Trade/Proprietary Name: Regulation Name:
Classification Regulation Product Code:
Device Class: Classification Panel
RECON system
Single/Multiple Component Metallic Bone Fixation Appliances and Accessories 21CFR 888.3030 HRS HWC HTN Class II Orthopedic
4
Image /page/4/Picture/2 description: The image is a logo for NORMED, a Zimmer company. The logo features the word "NORMED" in a bold, stylized font, with a globe graphic incorporated into the first letter. Above the logo, the text "The specialist for small bones" is written in a smaller font. Below the logo, the text "A ZIMMER COMPANY" is written in a smaller font.
4. Legally Marketed Predicate Device
K143165 - Herbert/Whipple Bone Screw System, Herbert Bone Screw, Herbert Cannulated Bone Screw System, and Herbert Mini Bone Screw
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
K022325 - Normed Titanium Osteotomy Plating System, manufactured by Normed Medizin-Technik GmbH, cleared September 9, 2009
K022231 - Normed Distal Radius Reconstruction System, manufactured by Normed Medizin-Technik GmbH, cleared September 13, 2002
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
K090675 - VLP Medial Column Fusion Plate - manufactured by Smith & Nephew Inc., cleared June 4. 2009
K121651 - Ortholoc 3DI Midfoot/Flatfoot System - manufactured by Wright Medical Technology, Inc. cleared October 12, 2012
K141784 - UltOS Plating System - manufactured by Ortho Solutions Limited, cleared July 23, 2014
K111678 - Ortho Solutions - Extremity Fixation Implants for Osteosynthesis- manufactured by Ortho Solutions Limited, cleared February 7, 2012
5
Image /page/5/Picture/2 description: The image shows the logo for NORMED, a Zimmer company. The logo is black and white, with 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" in a smaller font.
5. Device Description
The RECON system is a plate and screw system intended for internal fracture fixation. The system consists of the following plates:
- Reconstruction Plates 3.5, ●
- Medialis Plates 3.5, ●
- Universal Plates 3.5
- Universal Plates 3.5, H-shaped .
- USG Plates 3.5 ●
- Interpositioning Arthrodesis Plates ●
- Lapidus Plates ●
- . Dwyer Plates
screws and washers of different sizes and designs.
The plates, screws, and washers are either made of titanium alloy Ti-6AI-4V (ASTM F136) or commercially pure Titanium (C.P. Titanium; ASTM F67).
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.
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 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".
6. Indications for Use
The implants are intended to support normal bone healing for osteotomies, fractures, and reconstructions.
The RECON system consists of various system components and it is indicated for the treatment of fracture fixation, joint decompression and fusion, reconstruction or arthrodeses of small bones. The system can be used in both adult and pediatric patients. Additional information is provided in the corresponding surgical techniques.
7. Substantial Equivalence Discussion
The RECON system has the same intended use, similar performance characteristics, is manufactured from similar materials and is similar in design to the predicate devices.
7
Image /page/7/Picture/2 description: The image is a logo for NORMED, a Zimmer company. The logo features the text "NORMED" in a bold, sans-serif font, with the "O" replaced by a globe graphic. Above the logo, the text "The specialist for small bones" is written in a smaller font. Below the logo, the text "A ZIMMER COMPANY" is written in a smaller font, accompanied by the Zimmer logo.
8. Non-Clinical Performance Data
- -Biocompatibility - Biocompatibility testing on the plates, screws, and washer material 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 fatigue strength of the RECON System -plates and the predicate devices, the Zimmer Universal Locking System (ULS) Plates and Screws (K063303 and K060710) , resulted in similar mechanical properties and performance. The subject and predicate devices are substantially equivalent.
- -Self-tapping performance, driving and removal torque, to failure and axial pullout of the RECON System -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.
- -The subject washers are substantially equivalent to the washers cleared in K143066
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.
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 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 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.
8
Image /page/8/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 stylized font. Above the word "NORMED" is the text "The specialist for small bones". Below the word "NORMED" is the text "A ZIMMER COMPANY".
The RECON system is determined to be substantially equivalent to the referenced predicate devices.