(79 days)
Synthes Distal Femoral Nail, Synthes Cannulated Femoral Nail, DePuy ACE ART Femoral Nail
Not Found
No
The 510(k) summary describes a mechanical implant system for stabilizing bone fractures and does not mention any software, image processing, or AI/ML terms.
No
The device is a system of nails, blades, and caps designed to stabilize bone fractures, which is a structural support function rather than a therapeutic one (e.g., delivering medication, stimulating a biological response).
No.
The device description indicates it is a system of nails, spiral blades, and end caps used to stabilize fractures, which is a therapeutic function rather than a diagnostic one.
No
The device description explicitly states it is composed of physical components like femoral nails, spiral blades, and end caps, which are hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that the Synthes Retrograde/Antegrade Femoral Nail System is a surgical implant used to stabilize bone fractures. It is physically inserted into the body to provide structural support.
The device's function is entirely mechanical and surgical, not diagnostic based on analyzing biological samples.
N/A
Intended Use / Indications for Use
Synthes Retrograde/Antegrade Femoral Nail System is intended to stabilize fractures of the distal femur and the femoral shaft, including:
- · supracondylar fractures, including those with intraarticular extension
- · ipsilateral hip/shaft fractures
- ipsilateral femur/tibia fractures .
- femoral fractures in multiple trauma patients .
- fractures proximal to total knee arthroplasty .
- fractures distal to a hip implant .
- fractures in the morbidly obese
- fractures in osteoporotic bone .
- impending pathologic fractures .
- · malunions and nonunions
Product codes (comma separated list FDA assigned to the subject device)
IISB, HWC
Device Description
Synthes Retrograde/Antegrade Femoral Nail System is composed of femoral nails, spiral blades and end caps. Depending on the length of the nail, the nail may be inserted from a retrograde approach or from either a retrograde or antegrade approach. Spiral blades, end caps and Synthes commercially available locking bolts and screws are used to secure the nail in the bone, preventing rotation and axial compression.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal femur, femoral shaft, hip, femur, tibia
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)
Not Found
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.
Synthes Distal Femoral Nail, Synthes Cannulated Femoral Nail, and DePuy ACE ART Femoral Nail.
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
FEB - 5 2004
ATTACHMENT III: REVISED 510(k) SUMMARY
| Revised 510(k) Summary: | |
|---|---|
| Sponsor: | Synthes (USA)
1690 Russell Road
Paoli, PA 19301
(610) 647-9700 |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Bonnie Smith |
| Device Name: | Synthes (USA) Retrograde/Antegrade Femoral Nail System |
| Device Classification: | 21 CFR 888.3020 - "Intramedullary fixation rod"
21 CFR 888.3040 - "Smooth or threaded metallic bone
fixation fastener" |
| Predicate Device: | Synthes Distal Femoral Nail, Synthes Cannulated Femoral Nail, and
DePuy ACE ART Femoral Nail. |
| Description of Device: | Synthes Retrograde/Antegrade Femoral Nail System is composed of
femoral nails, spiral blades and end caps. Depending on the length of
the nail, the nail may be inserted from a retrograde approach or from
either a retrograde or antegrade approach. Spiral blades, end caps
and Synthes commercially available locking bolts and screws are
used to secure the nail in the bone, preventing rotation and axial
compression. |
| Indications: | Synthes Retrograde/Antegrade Femoral Nail System is intended to
stabilize fractures of the distal femur and the femoral shaft, including
supracondylar fractures, including those with intra-articular extension;
ipsilateral hip/shaft fractures; ipsilateral femur/tibia fractures; femoral
fractures in multiple trauma patients; fractures proximal to total knee
arthroplasty; fractures distal to a hip implant; fractures in the morbidly
obese; fractures in osteoporotic bone, impending pathologic fractures;
and malunions and nonunions. |
| Material: | Titanium alloy |
| Substantial Equivalence: | Documentation is provided which demonstrates that the Synthes
Retrograde/Antegrade Femoral Nail System is substantially
equivalent* to other legally marketed devices. |
| | * The term "substantially equivalent" as used in this 510(k) notification is
limited to the definition of substantial equivalence found in the Food, Drug,
and Cosmetic Act, as amended and as applied under 21 CFR 807, Subpart E,
under which a device can be marketed without pre-market approval or
reclassification. A determination of substantial equivalency under this
notification is not intended to have any bearing whatsoever on the resolution
of patent infringement suits or any other patent matter. No statements related
to, or in support of substantial equivalence herein shall be construed as an
admission against interest under the US Patent Laws or their application by the
courts. |
Ko3618
1
Image /page/1/Picture/1 description: The image is a circular seal or logo. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized symbol that resembles three wavy lines or stripes, possibly representing a flag or a symbol of movement and progress.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 5 2004
Ms. Bonnie J. Smith Senior Regulatory Affairs Associate Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli. Pennsylvania 19301
Re: K033618
Trade/Device Name: Synthes (USA) Retrograde/Antegrade Femoral Nail System Regulation Numbers: 21 CFR 888.3020 and 888.3040 Regulation Names: Intramedullary fixation rod and Smooth or threadcd metallic bone fixation fastener Regulatory Class: II Product Codes: IISB, HWC Dated: November 17, 2003 Received: November 18, 2003
Dear Ms. Smith:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can he 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); good manufacturing practice requirements as sct 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.
2
Page 2 - Ms. Bonnie J. Smith
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark A. Melleuson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): K033618
Device Name:
Indications for Use:
Synthes (USA) Retrograde/Antegrade Femoral Nail System
Synthes Retrograde/Antegrade Femoral Nail System is intended to stabilize fractures of the distal femur and the femoral shaft, including:
- · supracondylar fractures, including those with intraarticular extension
- · ipsilateral hip/shaft fractures
- ipsilateral femur/tibia fractures .
- femoral fractures in multiple trauma patients .
- fractures proximal to total knee arthroplasty .
- fractures distal to a hip implant .
- fractures in the morbidly obese �
- fractures in osteoporotic bone .
- impending pathologic fractures .
- · malunions and nonunions
(PILEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ✗
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
fo Mal A Millers