(68 days)
Not Found
No
The document describes a system of intramedullary nails and associated hardware for fracture fixation. There is no mention of AI or ML in the intended use, device description, or performance studies. The performance studies focus on shelf life, biocompatibility, and mechanical strength, which are typical for this type of device.
Yes
The device, an Intramedullary Fixation System, is used to stabilize various types of femoral, tibial, and humeral fractures. By fixing bone fractures, it directly contributes to the healing process and restoration of function, thus serving a therapeutic purpose.
No
Explanation: The device is an intramedullary fixation system (femoral, tibial, and humeral nails) used for treating various fractures, which classifies it as a therapeutic or surgical device, not a diagnostic one.
No
The device description explicitly states it includes physical components like femoral nails, retrograde femoral nails, tibial nails, humeral nails, self-tapping interlocking screws, nail caps, and cortical nuts, which are hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for the fixation of bone fractures in the femoral, tibial, and humeral shafts. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as cannulated stainless steel rods (nails) and associated hardware (screws, caps, nuts). These are physical implants used to stabilize bone.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The femoral nail is indicated for use in a variety of femoral fractures, such as:
- Subtrochanteric Fractures
- Intertrochanteric Fractures
- Comminuted Fractures
- Segmental Fractures
- Fractures with Bone Loss
- Proximal and Distal Fractures
- Nonunions
The retrograde femoral nail is indicated for use in a variety of retrograde type femoral fractures, such as:
- Closed Supracondylar Fractures
- Severely Comminuted Supracondylar Fractures with Articular Involvement
- Nonunions or Pseudoarthroses
- Malunions
- Pathological Fractures
- Fractures without Extensive Comminution
- Distal Fractures Involving Osteoporotic Bone
- Fractures Involving the Femoral Condyles that Require Open Knee Access
- T-Condylar Fractures
– Femoral Shaft Fracture with Attendant Femoral Neck Fractures (Nail to be Used in Conjunction with Fixation Screws or Plates as Needed) - Intertrochanteric Femoral Shaft Fractures
- Ipsilateral Femorotibial Fractures ("Floating Knee" Fractures)
- Femoral Shaft Fractures
- Bilateral Femoral Shaft Fractures
- Ipsilateral Patellofemoral Fractures
The tibial nail is indicated for use in a variety of tibial fractures, such as:
- Comminuted Fractures
- Segmental Fractures
- Fractures with Bone Loss
- Proximal and Distal Fractures
- Nonunions
- Transverse Fractures
- Oblique Fractures
- Spiral Fractures
- Bilateral Fractures
- Fractures with Butterfly Fragments
- Pseudarthrosis of the Tibial Shaft
- Corrective Osteotomies
The humeral nail is indicated for use in a variety of humeral fractures, such as:
- Comminuted Fractures
- Segmental Fractures
- Fractures with Bone Loss
- Proximal and Distal Fractures
— Nonunions - Delayed Unions
- Pathological Fractures
- Floating Elbow
– Nerve Lesion - Multiple Trauma Injuries
Product codes (comma separated list FDA assigned to the subject device)
HSB
Device Description
This submission covers line extensions and labeling changes to the Zimmer M/DN Intramedullary Fixation System. The Zimmer M/DN Intramedullary Fixation System is used for closed nailing of femoral, tibial, and humeral shaft fractures and includes femoral nails, retrograde femoral nails, tibial nails, humeral nails, self-tapping interlocking screws, nail caps, and cortical nuts. The nails are cannulated stainless steel rods with proximal and distal holes for insertion of interlocking screws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Femoral, tibial, and humeral shaft
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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 and Conclusions:
Shelf Life - Accelerated aging testing conducted shows that the sterile nails and screws included in this submission have a shelf life of 10 years. For the cortical nut and locking cap, real time testing shows that these specific devices have a shelf life of 5 years. Biocompatibility – Biocompatibility testing on the nail and screw material was conducted per ISO 10993 1 and Good Laboratory Practices (21 CFR 58). All testing passed
Performance Evaluation Engineering analyses were conducted for the Retrograde Femoral Nail line extensions and for the 5.5mm Cortical Nut and Nail Locking Cap to show that these devices were equivalent in strength to their respective predicate devices.
The results demonstrate that the devices are safe and effective and substantially equivalent to the predicate devices.
Clinical Performance and Conclusions: Clinical data and conclusions were not needed for these devices to show substantial equivalence.
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
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 image of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 15, 2015
Zimmer, Incorporated Mr. Stephen H. McKelvey Senior Project Manager, Trauma Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581
Re: K142281
Trade/Device Name: Zimmer M/DN Intramedullary Fixation System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: August 25, 2014 Received: August 26, 2014
Dear Mr. McKelvey:
This letter corrects our substantially equivalent letter of October 22, 2014.
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
(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 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/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) K142281
Device Name
Zimmer M/DN Intramedullary Fixation System
Indications for Use (Describe)
The femoral nail is indicated for use in a variety of femoral fractures, such as:
- Subtrochanteric Fractures
- Intertrochanteric Fractures
- Comminuted Fractures
- Segmental Fractures
- Fractures with Bone Loss
- Proximal and Distal Fractures
- Nonunions
The retrograde femoral nail is indicated for use in a variety of retrograde type femoral fractures, such as:
- Closed Supracondylar Fractures
- Severely Comminuted Supracondylar Fractures with Articular Involvement
- Nonunions or Pseudoarthroses
- Malunions
- Pathological Fractures
- Fractures without Extensive Comminution
- Distal Fractures Involving Osteoporotic Bone
- Fractures Involving the Femoral Condyles that Require Open Knee Access
- T-Condylar Fractures
– Femoral Shaft Fracture with Attendant Femoral Neck Fractures (Nail to be Used in Conjunction with Fixation Screws or Plates as Needed)
- Intertrochanteric Femoral Shaft Fractures
- Ipsilateral Femorotibial Fractures ("Floating Knee" Fractures)
- Femoral Shaft Fractures
- Bilateral Femoral Shaft Fractures
- Ipsilateral Patellofemoral Fractures
The tibial nail is indicated for use in a variety of tibial fractures, such as:
- Comminuted Fractures
- Segmental Fractures
- Fractures with Bone Loss
- Proximal and Distal Fractures
- Nonunions
- Transverse Fractures
- Oblique Fractures
- Spiral Fractures
- Bilateral Fractures
- Fractures with Butterfly Fragments
- Pseudarthrosis of the Tibial Shaft
- Corrective Osteotomies
3
The humeral nail is indicated for use in a variety of humeral fractures, such as: - Comminuted Fractures - Segmental Fractures - Fractures with Bone Loss - Proximal and Distal Fractures — Nonunions - Delayed Unions - Pathological Fractures - Floating Elbow – Nerve Lesion - Multiple Trauma Injuries 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)
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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K142281 Page 1 of 4
Image /page/4/Picture/1 description: The image contains the logo for Zimmer Biomet. The logo features a blue letter Z inside of a blue circle. Below the circle is the name "zimmer" in lowercase blue letters.
510(k) Summary
| Sponsor: | Zimmer, Inc.
P.O. Box 708
Warsaw, IN 46581-0708 |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Stephen H. McKelvey
Senior Project Manager, Trauma Regulatory Affairs
Telephone: (574) 372-4944
Fax: (574) 372-4605 |
| Date: | May 4, 2015 |
| Trade Name: | Zimmer® M/DN® Intramedullary Fixation System |
| Common Name: | Intramedullary Rod |
| Classification Name/Reference: | Rod, Intramedullary Fixation (21 CFR 888.3020, HSB) |
| Classification Panel: | Orthopedics/87 |
| Predicate Device(s): | Supracondylar Intramedullary Nail (Zimmer, K962561,
cleared September 25, 1996), Intramedullary Nail System
(Zimmer, K965098, cleared February 28, 1997), Zimmer
Natural Nail System Retrograde Femoral Nails (Zimmer,
K101622, cleared October 1, 2010) |
| Purpose and Device
Description: | This submission covers line extensions and labeling
changes to the Zimmer M/DN Intramedullary Fixation
System. The Zimmer M/DN Intramedullary Fixation
System is used for closed nailing of femoral, tibial, and
humeral shaft fractures and includes femoral nails,
retrograde femoral nails, tibial nails, humeral nails, self-
tapping interlocking screws, nail caps, and cortical nuts.
The nails are cannulated stainless steel rods with proximal
and distal holes for insertion of interlocking screws. |
| Intended Use: | The femoral nail is indicated for use in a variety of
femoral fractures, such as:
- Subtrochanteric Fractures
- Intertrochanteric Fractures
- Comminuted Fractures
- Segmental Fractures |
5
- Fractures with Bone Loss l
- | Proximal and Distal Fractures
- -Nonunions
The retrograde femoral nail is indicated for use in a variety of retrograde type femoral fractures, such as:
- Closed Supracondylar Fractures
- Severely Comminuted Supracondylar Fractures with l Articular Involvement
- Nonunions or Pseudoarthroses —
- Malunions —
- Pathological Fractures -
- -Fractures without Extensive Comminution
- Distal Fractures Involving Osteoporotic Bone —
- Fractures Involving the Femoral Condyles that Require Open Knee Access
- -T-Condylar Fractures
- । Femoral Shaft Fracture with Attendant Femoral Neck Fractures (Nail to be Used in Conjunction with Fixation Screws or Plates as Needed)
- -Intertrochanteric Femoral Shaft Fractures
- Ipsilateral Femorotibial Fractures ("Floating Knee" --Fractures)
- Femoral Shaft Fractures -
- Bilateral Femoral Shaft Fractures —
- -Ipsilateral Patellofemoral Fractures
The tibial nail is indicated for use in a variety of tibial fractures, such as:
- Comminuted Fractures
- Segmental Fractures --
- -Fractures with Bone Loss
- Proximal and Distal Fractures -
- -Nonunions
- -Transverse Fractures
- Oblique Fractures —
- Spiral Fractures -
- -Bilateral Fractures
- Fractures with Butterfly Fragments
- Pseudarthrosis of the Tibial Shaft —
- -Corrective Osteotomies
6
| | The humeral nail is indicated for use in a variety of
humeral fractures, such as:
-
Comminuted Fractures
-
Segmental Fractures
-
Fractures with Bone Loss
-
Proximal and Distal Fractures
-
Nonunions
-
Delayed Unions
-
Pathological Fractures
-
Floating Elbow
-
Nerve Lesion
-
Multiple Trauma Injuries |
|----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison to Predicate Device: | The Zimmer M/DN Intramedullary Fixation System nails,
screws, cortical nut, and locking cap covered by this
submission are similar in intended use, design, materials,
and performance characteristics to the predicate devices. |
| Performance Data (Nonclinical
and/or Clinical): | Non-Clinical Performance and Conclusions:
Shelf Life - Accelerated aging testing conducted
shows that the sterile nails and screws included in this
submission have a shelf life of 10 years. For the
cortical nut and locking cap, real time testing shows
that these specific devices have a shelf life of 5 years. Biocompatibility – Biocompatibility testing on the
nail and screw material was conducted per ISO 10993
1 and Good Laboratory Practices (21 CFR 58). All
testing passed | -
Performance Evaluation Engineering analyses • were conducted for the Retrograde Femoral Nail line extensions and for the 5.5mm Cortical Nut and Nail Locking Cap to show that these devices were equivalent in strength to their respective predicate devices.
The results demonstrate that the devices are safe and effective and substantially equivalent to the predicate devices.
7
Conclusions: The data presented in this submission show that the changes do not affect the safety and/or effectiveness of the subject devices and that the subject devices will perform in a substantially equivalent manner to the predicate devices.
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for these devices to show substantial equivalence.