(145 days)
Not Found
No
The summary describes a mechanical orthopedic implant and its testing, with no mention of AI or ML.
Yes.
The device, Dynamic Locking Screws, is used in combination with plates for the fixation of long bone fractures, osteotomies, and non-unions/malunions, which means it is intended to treat a disease or condition.
No
The device, Synthes Dynamic Locking Screws (DLS), is described as being used in combination with plates for the fixation of bone fractures and related conditions. Its description focuses on mechanical properties and function (allowing micro movement), not on diagnosing medical conditions or diseases.
No
The device description clearly describes a physical implantable device (screws) and mentions mechanical testing, indicating it is a hardware medical device.
Based on the provided information, 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, osteotomies, non-unions, and malunions. This is a surgical intervention performed directly on the patient's body.
- Device Description: The description details a mechanical implant (screws and plates) designed to provide structural support to 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
Synthes Dynamic Locking Screws (DLS) in combination with Synthes Locking Compression Plates (LCP) are intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
The 3.7mm / 5.0mm Dynamic Locking Screws are similar to locking screws, but feature a pin-in sleeve design. This design allows for micro movement within the angularly stable system and the screw-plate interface. The motion is contained within the DLS. The DLS are designed to be used with all applicable legally marketed Synthes Locking Compression Plates (LCP).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
long bone
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)
Testing conducted to support the substantial equivalence for the 3.7mm / 5.0mm Dynamic Locking Screws was aimed to assess the fatigue strength of the subject device. The Dynamic Locking Screws were tested evaluated in fatigue, insertion torque, fretting corrosion, and pullout resistance.
Testing using an ovine tibial osteotomy model was conducted to demonstrate lack of adverse effect on bone healing as compared to a predicate device.
The results of the evaluations confirm that the subject device is substantially equivalent to the predicate devices.
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.
K101696, K961413, K963192, K000682, K000684
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
K11 0592(i/2)
Image /page/0/Picture/1 description: The image shows the logo for Synthes. The logo consists of a stylized symbol on the left and the word "SYNTHES" in bold, sans-serif font on the right. A registered trademark symbol is located to the right of the "S" in "SYNTHES".
JUL 25 2011
5.0 - 510(k) Summary or 510(k) Statement
| Date Prepared: | 7/22/2011 |
|---|---|
| Purpose for Submission: | To introduce a new dynamic screw system (3.7mm / 5.0mm Dynamic Locking |
| Screws) into interstate commerce. | |
| Sponsor: | Synthes |
| Christopher Hack, Esq. | |
| 1301 Goshen Parkway | |
| West Chester, PA 19380 | |
| Tel: 610-719-6940 | |
| Fax: 484.356.9682 | |
| Device Name: | 3.7mm / 5.0mm Dynamic Locking Screws |
| Classification: | Class II |
| 888.3030 - smooth or threaded metallic bone fixation fastener | |
| HWC | |
| Predicate Device: | K101696 - Zimmer Motion Loc Screw for NCB Polyaxial Locking Plate |
| System | |
| K961413 - Synthes Anatomical Locking Plate System | |
| K963192 - Synthes 3.5/4.0mm Cannulated Screws | |
| K000682 - Synthes Large Fragment Dynamic Compression Locking | |
| System | |
| K000684 - Synthes Small Fragment Dynamic Compression Locking | |
| System | |
| Device Description: | The 3.7mm / 5.0mm Dynamic Locking Screws are similar to locking |
| screws, but feature a pin-in sleeve design. This design allows for micro | |
| movement within the angularly stable system and the screw-plate | |
| interface. The motion is contained within the DLS. The DLS are designed | |
| to be used with all applicable legally marketed Synthes Locking | |
| Compression Plates (LCP). | |
| Intended Use: | Synthes Dynamic Locking Screws (DLS) in combination with Synthes |
| Locking Compression Plates (LCP) are intended for use in long bone | |
| fractures, the fixation of osteopenic bone, the fixation of osteotomies, and | |
| for the fixation of non-unions and malunions. | |
| Substantial | |
| Equivalence: | The features of the subject components are substantially equivalent to the |
| predicate devices based on similarities in intended use and design. | |
| Mechanical testing demonstrates substantial equivalence of the subject | |
| components to the predicate device in regards to mechanical strength. In | |
| addition, the intended use, manufacturing methods, packaging, and | |
| sterilization of the predicate and subject components are identical. | |
| Functional and mechanical testing demonstrates the comparable | |
| mechanical & functional properties of the subject device: 3.7mm / 5.0mm | |
| Dynamic Locking Screws to the predicate devices. | |
| Testing conducted to support the substantial equivalence for the 3.7mm / |
1
K110592(2/2
Image /page/1/Picture/1 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a design inside. A small circle with a registered trademark symbol is located to the right of the word.
5.0mm Dynamic Locking Screws was aimed to assess the fatigue strength of the subject device. The Dynamic Locking Screws were tested evaluated in fatigue, insertion torque, fretting corrosion, and pullout resistance.
Testing using an ovine tibial osteotomy model was conducted to demonstrate lack of adverse effect on bone healing as compared to a predicate device.
The results of the evaluations confirm that the subject device is substantially equivalent to the predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name encircling a stylized image. The image in the center appears to be an abstract representation of a human figure or a symbol related to health and well-being. The text is arranged around the perimeter of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Synthes % Mr. Christopher Hack, Esq. Senior Regulatory Specialist 1301 Goshen Parkway West Chester, Pennsylvania
JUL 25 2011
Re: K110592
Trade/Device Name: 3.7mm/5.0mm Dynamic Locking Screws Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliance and accessories Regulatory Class: Class II Product Code: HWC Dated: June 22, 2011 Received: June 24, 2011
Dear Mr. Hack:
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 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
3
Page 2 - Mr. Christopher Hack, Esq.
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours,
Eino Keith
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Image /page/4/Picture/1 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a logo that appears to be a stylized representation of a person. A small circle with an "R" inside is located to the right of the word.
Attachment E - Indications for Use Statement
510(k) Number (if known):
3.7mm / 5.0mm Dynamic Locking Screws Device Name:
Indications for Use:
Synthes Dynamic Locking Screws (DLS) in combination with Synthes Locking Compression Plates (LCP) are intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.
Prescription Use X (Per 21 CFR 801.109)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
for M. Melkerson
(Division Sign-Diff) (Division Sign-Dir))
Division of Surgical, Orthopedic, Division of Style
and Restorative Devices
510(k) Number K110592
AZ