(44 days)
No
The summary describes a system of bone plates and screws for fracture fixation and fusion, with no mention of software, algorithms, or any technology that would typically incorporate AI/ML. The performance studies focus on biocompatibility and mechanical properties.
Yes.
The device is an implantable plate system designed for fracture fixation, joint decompression, fusion, and reconstruction of small bones, which are therapeutic interventions.
No
This device, the RECON system – MPJ plates, is described as a plate system intended for internal fracture fixation. Its purpose is to support bone healing and perform fusions or reconstructions, which are all treatment-oriented actions rather than diagnostic ones.
No
The device description clearly states that the system consists of plates made of titanium alloy or commercially pure titanium, which are physical hardware components. The summary also mentions biocompatibility and mechanical performance testing, which are relevant to hardware devices.
Based on the provided text, 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 system for internal fracture fixation, made of titanium alloy. This is consistent with a surgical implant, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) or to provide information about a patient's health status through in vitro examination.
The device is a surgical implant used to physically stabilize and support bone structures.
N/A
Intended Use / Indications for Use
The implants are intended to support normal bone healing for osteotomies, fractures, and reconstructions.
The RECON system – MPJ Plates 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 for adult patients. Additional information is provided in the corresponding surgical techniques.
MP-Joint Fusion Plates 2.7
The MP-Joint Fusion Plates 2.7 combined with the Standard/Locking Screws 2.7 are indicated for the arthrodesis of the first metatarso-phalangeal joint.
- Plate size S is indicated for standard MP-Joint fusions.
- Plate Sizes M/L are indicated for standard MP-Joint fusion and interpositioning / revision fusions with bone graft (f.e. for revision of Keller-Brandes).
Universal Reconstruction Plates 2.7
The Universal Reconstruction Plates 2.7 combined with Standard/Locking Screws 2.7 are indicated for revision of MP-joint fusion and for reconstruction procedures in forefoot and midfoot.
docPrice Revision Plates 2.7/3.5
The docPrice Revision Plates 2.7/3.5 combined with the Standard/Locking Screws 2.7/3.5 are indicated for MTP I lengthening osteotomy and/or arthrodesis, especially indicated for cases of Keller-Brandes revisions, revisions after MTP I prosthesis and lengthening of short first toe.
Product codes
HRS
Device Description
The RECON system – MPJ plates is a plate system intended for internal fracture fixation. The system consists of the following plates:
- MP - Joint Fusion Plates 2.7,
- Universal Reconstructions Plates 2.7,
- docPrice Revision Plates 2.7/3.5
of different sizes and designs.
The plates are either made of titanium alloy Ti-6Al-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 or for single use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
small bones, first metatarso-phalangeal joint, forefoot and midfoot
Indicated Patient Age Range
adult 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
Non-Clinical Performance Data:
- 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 fatigue strength of the RECON System-MPJ plates 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.
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.
Key Metrics
Not Found
Predicate Device(s)
K010321, K063303, K060710, K143066
Reference Device(s)
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human profiles. The symbol is rendered in black and white.
September 16, 2015
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Normed Medizin-Technik Gmbh Arne Briest RA/QA Manager Ulrichstrasse 7 Tuttlingen, D-78532 Germany
Re: K152142
Trade/Device Name: Recon System - MPJ Plates Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances and Accessories Regulatory Class: Class II Product Code: HRS Dated: July 31, 2015 Received: August 3, 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 Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K152142
Device Name RECON system - MPJ Plate
Indications for Use (Describe)
The implants are intended to support normal bone healing for osteotomies, fractures, and reconstructions.
The RECON system - MPJ Plates 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 for adult patients. Additional information is provided in the corresponding surgical techniques.
MP -- Joint Fusion Plates 2.7
The MP-Joint Fusion Plates 2.7 combined with the Standard/Locking Screws 2.7 are indicated for the arthrodesis of the first metatarso--phalangeal joint.
· Plate size S is indicated for standard MP -- Joint fusions.
· Plate Sizes M/L are indicated for standard MP--Joint fusion and interpositioning / revision fusions with bone graft (f.e. for revision of Keller--Brandes).
Universal Reconstruction Plates 2.7
The Universal Reconstruction Plates 2.7 combined with Standard/Locking Screws 2.7 are indicated for revision of MP--ioint fusion and for reconstruction procedures in forefoot and midfoot.
docPrice Revision Plates 2.7/3.5
The docPrice Revision Plates 2.7/3.5 combined with the Standard/Locking Screws 2.7/3.5 are indicated for MTP I lengthening osteotomy and/or arthrodesis, especially indicated for cases of Keller-Brandes revisions, revisions after MTP I prosthesis and lengthening of short first toe.
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)
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Image /page/3/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".
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 #: 9611091
2. Date Prepared
Date Prepared:
August 21, 2015
Device Identification 3.
Trade/Proprietary Name: RECON system – MPJ Plates Single/Multiple Component Metallic Bone Fixation Regulation Name: Appliances and Accessories Classification Regulation 21CFR 888.3030 HRS Product Code: Device Class: Class II Classification Panel Orthopedic
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Image /page/4/Picture/2 description: The image is a logo for NORMED, a company that specializes in small bones. The logo is black and white and features the company name in a bold, sans-serif font. Above the company name is the text "The specialist for small bones". Below the company name is the text "A ZIMMER COMPANY".
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
K011335 - Synthes Ti 3.5 mm One third tubular plate, manufactured by Synthes Inc., cleared July 27, 2001
K151407- RECON System manufactured by Normed Medizin-Technik GmbH., cleared August 12, 2015
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Image /page/5/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 a graphic of a globe and radar in place of the "O." Below the logo, it says "A ZIMMER COMPANY" with a blue Z logo.
5. Device Description
The RECON system – MPJ plates is a plate system intended for internal fracture fixation. The system consists of the following plates:
- MP - Joint Fusion Plates 2.7,
- . Universal Reconstructions Plates 2.7,
- . docPrice Revision Plates 2.7/3.5
of different sizes and designs.
The plates are either made of titanium alloy Ti-6Al-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 or for single use.
6
Image /page/6/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 with a graphic of a globe with crosshairs. Below the word "NORMED" is the text "A ZIMMER COMPANY" with the Zimmer logo to the left.
6. Indications for Use
The implants are intended to support normal bone healing for osteotomies, fractures, and reconstructions.
The RECON system – MPJ Plates 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 for adult patients. Additional information is provided in the corresponding surgical techniques.
MP-Joint Fusion Plates 2.7
The MP-Joint Fusion Plates 2.7 combined with the Standard/Locking Screws 2.7 are indicated for the arthrodesis of the first metatarso-phalangeal joint.
- Plate size S is indicated for standard MP-Joint fusions.
- . Plate Sizes M/L are indicated for standard MP-Joint fusion and interpositioning / revision fusions with bone graft (f.e. for revision of Keller-Brandes).
Universal Reconstruction Plates 2.7
The Universal Reconstruction Plates 2.7 combined with Standard/Locking Screws 2.7 are indicated for revision of MP-joint fusion and for reconstruction procedures in forefoot and midfoot.
docPrice Revision Plates 2.7/3.5
The docPrice Revision Plates 2.7/3.5 combined with the Standard/Locking Screws 2.7/3.5 are indicated for MTP I lengthening osteotomy and/or arthrodesis, especially indicated for cases of Keller-Brandes revisions, revisions after MTP I prosthesis and lengthening of short first toe.
7. Substantial Equivalence Discussion
The RECON system - MPJ plates have intended use, similar performance characteristics, is manufactured from similar materials and is similar in design to the predicate devices.
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Image /page/7/Picture/2 description: The image is a logo for NORMED, "The specialist for small bones", which is a Zimmer company. The logo is black and white and features the word "NORMED" in a bold, sans-serif font. The "O" in NORMED is replaced with a graphic of a globe with a target over it. Below the word "NORMED" is the text "A ZIMMER COMPANY" in a smaller, sans-serif font.
8. Non-Clinical Performance Data
- -Biocompatibility - Biocompatibility testing on the plates was conducted and evaluated per ISO 10993-1. All testing passed.
- । Cross sectional enqineering analysis of the plates, proof load, bending strength, bending stiffness, equivalent bending stiffness and fatigue strength of the RECON System-MPJ plates 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.
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- MPJ Plates 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 – MPJ Plates 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 – MPJ Plates are determined to be substantially equivalent to the referenced predicate devices.