(28 days)
Not Found
No
The description focuses on the mechanical properties and materials of the intramedullary nails and associated hardware, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as an intramedullary nail system intended for temporary fracture fixation and stabilization of the bone, which is a therapeutic purpose.
No
The device is described as a system for temporary fracture fixation and stabilization of the bone, not for diagnosing conditions.
No
The device description explicitly states it is a "family of temporary fixation intramedullary nails" made of Ti-6Al-4V alloy, which are physical hardware components.
Based on the provided information, the Zimmer Natural Nail System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "temporary fracture fixation and stabilization of the bone" in the femur. This is a surgical intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a physical implant (intramedullary nail, screws, caps, etc.) made of metal and plastic, designed to be surgically inserted into the bone. This is characteristic of a medical device used for treatment, not diagnosis.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
Therefore, the Zimmer Natural Nail System falls under the category of a surgical implant or orthopedic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
ANTEGRADE FEMORAL NAILS: The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone. Indications for use of the Greater Trochanter and Piriformis Fossa Antegrade Femoral nails in the femur include:
- Compound and simple shaft fractures
- Proximal, metaphyseal and distal shaft fractures
- Segmental fractures
- Comminuted fractures
- Fractures involving osteopenic and osteoporotic bone
- Pathological fractures
- Fractures with bone loss
- Pseudoarthrosis, non-union, mal-union and delayed union
- Periprosthetic fractures
- Surgically created defects such as osteotomies
- Intertrochanteric and subtrochanteric fractures
RETROGRADE FEMORAL NAILS: The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone. Indications for use of the retrograde femoral nails in the femur include:
- Compound and simple shaft fractures
- Proximal, metaphyseal, and distal shaft fractures
- Segmental fractures
- Closed supracondylar fractures
- Severely comminuted supracondylar fractures with articular involvement
- Fractures involving femoral condyles
- Comminuted fractures
- Fractures involving osteopenic and osteoporotic bone
- Pathological fractures
- Fractures with bone loss
- Pseudoarthrosis, non-union, and mal-union
- Periprosthetic fractures
- Poly trauma patients
Product codes (comma separated list FDA assigned to the subject device)
HSB
Device Description
The Zimmer Natural Nail System is a family of temporary fixation intramedullary nails designed for fracture fixation and stabilization of the femur. The nails are available in a variety of lengths and diameters to meet the assorted anatomical needs. Each of the intramedullary nails is secured by a series of screws that pass through holes manufactured into the proximal and distal sections of each nail. Nail caps, cortical washers and cortical nuts are available for use with the system. All components are made of Ti-6Al-4V alloy. The cortical nut also contains UHMWPE.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Femur
Indicated Patient Age Range
Not Found
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 Tests:
- Screw Three Point Bend Test
- Proximal Nail Fatigue Construct Test
- Distal Nail Fatigue Construct Test
- Testing has been performed to establish product non-pyrogenicity
Clinical Tests:
- N/A
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.
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
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.
0
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Zimmer Inc. Dhaval Saraiya Regulatory Affairs Senior Specialist 345 East Main Street Warsaw, Indiana 46580
Re: K172114
Trade/Device Name: Zimmer Natural Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: July 10, 2017 Received: July 13, 2017
Dear Mr. Saraiya:
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-
Image /page/0/Picture/10 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is written in a simple, sans-serif font.
August 10, 2017
1
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 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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
2301V932 ИАМИН ОНА НТЈАЭН ЗО ТИЭМТЯАЧЭО Food and Drug Administration
udications for Use
See PRA Statement below Expiration Date: January 31, 2017 Form Approved: OMBBIolo. 0900-0120
510(k) Number (if know
77777717
Device Name Zimmer Natural Nail System
Indications for Use (Describe)
ANTEGRADE FEMORAL NAILS:
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FOR CONTINUOUS MONITORING AND
PERIODIC INSPECTIONS OF THE VISUAL
CONDITIONS FOR THE INTEGRITY OF
CONTAINMENT AND ASSOCIATED
COMPONENTS
- Proximal, metaphyseal and distal shaft fractures Componing and simple shaft fractures
- Segmental fractures
- Comminuted fractures
- Fractures involving osteopenic and osteoporotic bon
- Pathological fractures
- Fractures with bone loss
- and partirosis, pur noinn-lem (university of the desires and
- Periprosthetic fractures
- Surgically created defects such as osteotomies
- Interfrochanteric and subtrochanteric fracture
RETROGRADE FEMORAL NAILS:
on one in formations but unders in the firsten from the first list. Inches of t Innications for use of the retroges ade femore in the femur include:
- Compound and simple shaft fractures
- Proximal, metaphyseal and distal shaft fractures
- Segmental fractures
- Closed supracondylar fractures
- Severy commininted supracondy lar fractures with articular involvement
- Fractures involving femoral condyles
- Comminuted fractures
- Fractures involving osteopenic and osteoporotic bon
- Pathological fractures
- Fractures with bone loss
- Pseudoarthrosis, non-union, and mal-unio
- Periprosthefic fractures
- Poly frauna patients
FORM FDA 3888 (8814
Page 1 of 2
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Image /page/4/Picture/0 description: The image shows the logo for Zimmer Biomet. The logo features a large, stylized blue letter "Z" enclosed in a blue circle. Below the circle, the word "zimmer" is written in lowercase blue letters, using a modern sans-serif font.
510(k) Summary
In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the Zimmer Natural Nail (ZNN) – 6.0mm Fixed Angle Screws 510(k) premarket notification.
| Sponsor: | Zimmer, Inc.
345 E Main St
Warsaw, IN 46580
Establishment Registration Number: 1822565 | | |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|-------------|
| Contact Person: | Dhaval Saraiya
Regulatory Affairs Sr. Specialist
Telephone: (305-269-6386)
Fax: (305-269-6400) | | |
| Date: | August 9, 2017 | | |
| Subject Device: | Trade Name: Zimmer Natural Nail System
Common Name: Intramedullary Fixation Road
Classification Name:
• HSB- Rod, Fixation, Intramedullary and Accessories
(21 CFR 888.3020) | | |
| Predicate Device(s): | K083497 | Zimmer Natural Nail System Piriformis
Fossa and Greater
Trochanter Antegrade
Femoral Nails | Zimmer Inc. |
| | K101622 | Zimmer Natural
System Retrograde
Femoral Nails | Zimmer Inc. |
| Purpose and Device
Description: | The intent of this premarket notification is to provide new
mechanical testing data for the Zimmer Natural Nail
System - 6.0mm Fixed Angle Screws which is different
than the performance specifications submitted in the
original premarket notifications mentioned above. The
reason for two predicate devices being identified in this
submission is because these screws are used with both
Zimmer Natural Nail System - Piriformis Fossa and Greater | | |
5
Trochanter Antegrade Femoral Nails and Retrograde Femoral Nails and different sizes were cleared in both submissions. Since these screws are used for various nails in the same product family, we think that this still qualifies as a special 510(k) submission.
The Zimmer Natural Nail System is a family of temporary fixation intramedullary nails designed for fracture fixation and stabilization of the femur. The nails are available in a variety of lengths and diameters to meet the assorted anatomical needs. Each of the intramedullary nails is secured by a series of screws that pass through holes manufactured into the proximal and distal sections of each nail. Nail caps, cortical washers and cortical nuts are available for use with the system. All components are made of Ti-6Al-4V alloy. The cortical nut also contains UHMWPE.
Intended Use and Indications for Use:
ANTEGRADE FEMORAL NAILS:
The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone. Indications for use of the Greater Trochanter and Piriformis Fossa Antegrade Femoral nails in the femur include:
- Compound and simple shaft fractures
- · Proximal, metaphyseal and distal shaft fractures
- Segmental fractures
- · Comminuted fractures
- · Fractures involving osteopenic and osteoporotic bone
- Pathological fractures
- Fractures with bone loss
- · Pseudoarthrosis, non-union, mal-union and delayed union
- Periprosthetic fractures
- · Surgically created defects such as osteotomies
- · Intertrochanteric and subtrochanteric fractures
RETROGRADE FEMORAL NAILS:
The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone. Indications for use of the retrograde femoral nails in the femur include:
- · Compound and simple shaft fractures
- Proximal, metaphyseal, and distal shaft fractures
- Segmental fractures
- Closed supracondylar fractures
6
- Severely comminuted supracondylar fractures with articular involvement
- · Fractures involving femoral condyles
- · Comminuted fractures
- · Fractures involving osteopenic and osteoporotic bone
- Pathological fractures
- Fractures with bone loss
- · Pseudoarthrosis, non-union, and mal-union
- · Periprosthetic fractures
- Poly trauma patients
Summary of Technological Characteristics:
The rationale for substantial equivalence is based on consideration of the following characteristics:
- Intended Use: Same as the predicate device
- Indications for Use: Same as the predicate device
- Materials: Same as the predicate device ●
- Design Features: Same as the predicate device ●
- . Sterilization: Same as the predicate device
Summary of Performance Data (Nonclinical and/or Clinical)
● Non-Clinical Tests:
- Screw Three Point Bend Test O
- Proximal Nail Fatigue Construct Test o
- Distal Nail Fatigue Construct Test O
- Testing has been performed to establish product o non-pyrogenicity
- Clinical Tests: ●
- o N/A
Substantial Equivalence Conclusion
The information provided within this premarket notification demonstrates that the Zimmer Natural Nail System Screws are substantially equivalent to the predicate devices.