(252 days)
Not Found
No
The device description and performance studies focus solely on the mechanical properties and materials of bone screws and washers, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes.
The device is intended to support normal bone healing for osteotomies, non-unions, and reconstructions, and is indicated for the treative fixation, nonunions, joint decompression and fusion, osteotomies, reconstruction, or arthrodeses of bones, all of which are considered therapeutic functions.
No
This device is designed for fixation of bones and reconstruction therapies, indicating a therapeutic rather than diagnostic purpose.
No
The device description explicitly states the system consists of screws and washers made of titanium alloy, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "support normal bone healing for osteotomies, non-unions and reconstructions" and for "treative fixation, nonunions, joint decompression and fusion, osteotomies, reconstruction or arthrodeses of bones." This describes a surgical implant used directly on the patient's body to treat a physical condition.
- Device Description: The device is described as "compression screws" made of titanium alloy, intended for "internal fracture fixation." These are physical implants.
- Lack of IVD Characteristics: An IVD device is used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided description does not mention any such use or interaction with bodily specimens for diagnostic purposes.
The device described is a surgical implant used for orthopedic procedures, which falls under the category of medical devices, but not specifically In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The implants are intended to support normal bone healing for osteotomies, non-unions and reconstructions.
The RECON system consists of various system components and it is indicated for the treative fixation, non-unions, joint decompression and fusion, osteotomies, reconstruction or arthrodeses of bones. The system can be used in adult patients. Additional information is provided in the corresponding surgical techniques.
Product codes (comma separated list FDA assigned to the subject device)
HWC, HTN
Device Description
The RECON system -compression screws are intended for internal fracture fixation. The system consists of the following screws:
- Microcan 1.8/2.3 ●
- . Maxican 4.5
- CBS Micro Compression ●
- CBS High Compression
- CBS 4.5/7.5 ●
- V-TEK Micro 2.0 ●
- V-TEK Standard 3.0 ●
screws of different sizes and designs.
The screws and washers 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 as well as plate sizes and configurations.
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
bones
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Data
- Biocompatibility Biocompatibility testing on screws, and washer material was conducted and evaluated per ISO 10993-1. All testing passed.
- -Self-tapping performance, driving and removal torque, torgue to failure and axial pullout of the RECON system- compression 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, Herbert Mini Bone Screw (K143165) and NCB Plating System (K061211, K042695) resulted in similar mechanical properties and performance. The subject and predicate devices are substantially equivalent.
- -The subjected washer is substantially equivalent to the washers cleared in K151407.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K143165, K061211, K042695, K063303/K060710, K032634, K022324, K151407
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which consists of a stylized human figure with three profiles overlapping each other. The emblem is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 2, 2016
Normed Medizin-Technik GmbH Mr. Arne Briest RA/QA Manager Ulrichstrasse 7 D-78532 Tuttlingen Germany
Re: K151708
Trade/Device Name: RECON system - Compression Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, HTN Dated: January 29, 2016 Received: February 1, 2016
Dear Mr. 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 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
1
Page 2 - Mr. Arne Briest
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/Resourcesfor You/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 vours.
Lori A. Wiggins -S
for Mark N. 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) K151708
Device Name RECON system - Compression Screws
Indications for Use (Describe)
The implants are intended to support normal bone healing for osteotomies, non-unions and reconstructions.
The RECON system consists of various system components and it is indicated for the treative fixation, nonunions, joint decompression and fusion, osteotomies, reconstruction or arthrodeses of bones. The system can be used in adult 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."
FORM FDA 3881 (1/14)
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Image /page/3/Picture/2 description: The image is a logo for NORMED, a Zimmer company. The text "The specialist for small bones" is above the NORMED logo. The N in NORMED has a graphic of the earth in the center of the letter.
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
March 1, 2016
3. Device Identification
Trade/Proprietary Name: Common/Usual Name: Classification Name: Classification Regulation Product Code:
Device Class: Classification Panel
RECON system - Compression Screws screws Screw, Fixation, Bone 21CFR 888.3040 HWC HTN Class II Orthopedic
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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 incorporated into the letter "O". Above the logo is the text "The specialist for small bones". Below the logo is the text "A ZIMMER COMPANY" with a stylized Z to the left.
| 4. Legally Marketed Predicate Device | |
|---|---|
| K143165 | - Herbert/Whipple Bone Screw System, Herbert Bone Screw, Herbert Cannulated Bone Screw System, and Herbert Mini Bone Screw |
| K061211 | - NCB Plating System |
| K042695 | - NCB Plating System |
| K063303/ | |
| K060710 | - Zimmer Universal Locking System (ULS) Plates and Screws |
| K032634 | - Normed Compression Bone Screw System |
| K022324 | - Normed Titanium Osteotomy Plating System |
| K151407 | - Normed RECON System |
5. Device Description
The RECON system -compression screws are intended for internal fracture fixation. The system consists of the following screws:
- Microcan 1.8/2.3 ●
- . Maxican 4.5
- CBS Micro Compression ●
- CBS High Compression
- CBS 4.5/7.5 ●
- V-TEK Micro 2.0 ●
- V-TEK Standard 3.0 ●
screws of different sizes and designs.
The screws and washers 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 as well as plate sizes and configurations.
The implants are provided non-sterile and single-use only. The instruments are non-sterile and reusable.
5
Image /page/5/Picture/2 description: The image is a logo for NORMED, a Zimmer company. The logo is black and white, with the words "NORMED" in large, bold letters. Above the word "NORMED" is the phrase "The specialist for small bones". Below the word "NORMED" is the phrase "A ZIMMER COMPANY" in smaller letters. To the left of the word "NORMED" is a graphic of the earth.
6. Indications for Use
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, non-unions, joint decompression and fusion, osteotomies, reconstruction or arthrodeses of bones. The system can be used in adult patients.
Additional information is provided in the corresponding surgical techniques.
7. Substantial Equivalence Discussion
The RECON system-compression screws have the same intended use, similar performance characteristics, are manufactured from similar materials and are similar in design to the predicate devices.
8. Non-Clinical Performance Data
- Biocompatibility Biocompatibility testing on screws, and washer material was conducted and evaluated per ISO 10993-1. All testing passed.
- -Self-tapping performance, driving and removal torque, torgue to failure and axial pullout of the RECON system- compression 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, Herbert Mini Bone Screw (K143165) and NCB Plating System (K061211, K042695) resulted in similar mechanical properties and performance. The subject and predicate devices are substantially equivalent.
- -The subjected washer is substantially equivalent to the washers cleared in K151407.
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.
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Image /page/6/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 phrase "The specialist for small bones". Below the word "NORMED" is the phrase "A ZIMMER COMPANY".
10. Statement of Substantial Equivalence
By definition, a device is substantially equivalent to a predicate device when the 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 systemcompression 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 -compression 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-compression screws are determined to be substantially equivalent to the referenced predicate devices.