(294 days)
No
The device description focuses on mechanical components (plates, screws, instruments) and their physical properties and testing. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is a system of metallic plates and screws used for fracture fixation, not a therapeutic device designed to cure or prevent disease. It is a surgical implant for structural support.
No
The device is a system of plates and screws intended for fracture fixation and reconstructive procedures. It is used for treatment, not for diagnosing medical conditions.
No
The device description explicitly states it consists of "metallic plates and screws" and "instruments," which are physical hardware components, not software.
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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The provided description clearly states that the DePuy Synthes Variable Angle Locking Hand System consists of "metallic plates and screws" intended for "fracture fixation of the hand and other small bones and small bone fragments." These are physical implants used in surgical procedures.
- Intended Use: The intended use is for surgical fixation of fractures, mal-unions, non-unions, etc., which are all procedures performed directly on the patient's body, not on samples taken from the body.
The device is a surgical implant system, not a diagnostic test performed on biological samples.
N/A
Intended Use / Indications for Use
The DePuy Synthes Variable Angle Locking Hand System is intended for fracture fixation of the hand and other small bones and small bone fragments, in adults and adolescents (12-21) particularly in osteopenic bone.
System indications include the following:
- Open reduction and internal fixation of fractures, mal-unions, and non-unions
- Following excision of benign bone tumors
- Replantations and reconstructions
- Arthrodeses of joints involving small bones
- Osteotomies, including deformity correction such as rotation, lengthening, shortening
- Pathological fractures, including impending pathologic fractures
Product codes
HRS, HWC
Device Description
The DePuy Synthes Variable Angle Locking Hand System consists of metallic plates and screws that offer screw-to-plate locking designed for various fracture modes of the hand. Generally, the system consists of plates, screws, and instruments which feature variable angle locking technology. The plates contained in the DePuy Synthes Variable Angle Locking Hand System are offered in a range of configurations to accommodate patient anatomy and surgical need. The plates are designed to accept existing 1.5mm cortex screws (K090047), previously cleared 1.5mm Locking Screws at the nominal angle only (K090047), and new 1.5mm VA Locking Screws. The new 1.5mm VA Locking Screws feature existing variable angle locking technology (K100776, K120689, K110354), and are designed to fit in the 1.5mm holes of the subject plates.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand and other small bones and small bone fragments
Indicated Patient Age Range
adults and adolescents (12-21)
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 information has been provided in support of the performance of the subject system as follows:
- Finite Element Analysis to determine worst case constructs
- Dynamic Fatigue Testing on representative constructs
- Torsional properties of 1.5mm VA Locking Screws per ASTM F543
- Pullout strength of 1.5mm VA Locking Screws per ASTM F543
- Insertion Torque of 1.5mm VA Locking Screws per ASTM F543
Literature has been provided to support the revision in indications, including the addition of the adolescent population.
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 1.5mm LCP Mini-Fragment System (K090047), Synthes Locking Hand Plates (K092247), Synthes Stainless Steel Modular Hand System (K030310), Synthes VA Locking Screws (K100776, K120689, K110354)
Reference Device(s):
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
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 30, 2015
Synthes USA Mr. Nicholas Fountoulakis Regulatory Affairs Specialist 1301 Goshen Parkway West Chester, Pennsylvania 19380
Re: K141527
Trade/Device Name: DePuy Synthes Variable Angle Locking Hand System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: February 18, 2015 Received: February 19, 2015
Dear Mr. Fountoulakis:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
Page 2 – Mr. Nicholas Fountoulakis
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" (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 yours.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
DePuySynthes Variable Angle Locking Hand System
Indications for Use (Describe)
The DePuy Synthes Variable Angle Locking Hand System is intended for fracture fixation of the hand and other small bones and small bone fragments, in adults and adolescents (12-21) particularly in osteopenic bone.
System indications include the following:
- · Open reduction and internal fixation of fractures, mal-unions, and non-unions
- · Following excision of benign bone tumors
- · Replantations and reconstructions
- · Arthrodeses of joints involving small bones
- · Osteotomies, including deformity correction such as rotation, lengthening, shortening
- · Pathological fractures, including impending pathologic fractures
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 FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR
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:
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3
510(k) Summary
Date Prepared: March 16, 2015
| Date Prepared: | March 16, 2015 |
|---|---|
| Sponsor: | DePuy Synthes |
| Nicholas Fountoulakis | |
| 1301 Goshen Parkway | |
| West Chester, PA 19380 | |
| Office: (610) 719-6553 | |
| Fax: (484)-356-9682 | |
| Proprietary | |
| Name: | DePuy Synthes Variable Angle Locking Hand System |
| Classification: | Classification: §888.3030, §888.3040 |
| Product Code: HRS, HWC | |
| Predicate | |
| Device: | Synthes 1.5mm LCP Mini-Fragment System (K090047) |
| Synthes Locking Hand Plates (K092247) | |
| Synthes Stainless Steel Modular Hand System (K030310) | |
| Synthes VA Locking Screws (K100776, K120689, K110354) | |
| Device | |
| Description: | The DePuy Synthes Variable Angle Locking Hand System consists of metallic plates |
| and screws that offer screw-to-plate locking designed for various fracture modes of | |
| the hand. Generally, the system consists of plates, screws, and instruments which | |
| feature variable angle locking technology. The plates contained in the DePuy Synthes | |
| Variable Angle Locking Hand System are offered in a range of configurations to | |
| accommodate patient anatomy and surgical need. The plates are designed to accept | |
| existing 1.5mm cortex screws (K090047), previously cleared 1.5mm Locking Screws | |
| at the nominal angle only (K090047), and new 1.5mm VA Locking Screws. The new | |
| 1.5mm VA Locking Screws feature existing variable angle locking technology | |
| (K100776, K120689, K110354), and are designed to fit in the 1.5mm holes of the | |
| subject plates. | |
| Indications for | |
| Use: | The DePuy Synthes Variable Angle Locking Hand System is intended for fracture |
| fixation of the hand and other small bones and small bone fragments, in adults and | |
| adolescents (12-21) particularly in osteopenic bone. | |
| System indications include the following: | |
| Open reduction and internal fixation of fractures, mal-unions, and non- | |
| ● | |
| unions | |
| Following excision of benign bone tumors | |
| ● | |
| Replantations and reconstructions | |
| ● | |
| Arthrodeses of joints involving small bones | |
| ● | |
| Osteotomies, including deformity correction such as rotation, | |
| ● | |
| lengthening, shortening | |
| Pathological fractures, including impending pathologic fractures | |
| ● | |
| Substantial | |
| Equivalence: | The proposed DePuy Synthes Variable Angle Locking Hand System shares the same |
| fundamental technological characteristics as the predicate systems (K090047, | |
| K092247, K100776, K120689, and K110354). | |
| Non-Clinical information has been provided in support of the performance of the | |
| subject system as follows: | |
| Finite Element Analysis to determine worst case constructs | |
| ● | |
| Dynamic Fatigue Testing on representative constructs | |
| ● | |
| Torsional properties of 1.5mm VA Locking Screws per ASTM F543 | |
| ● | |
| Pullout strength of 1.5mm VA Locking Screws per ASTM F543 | |
| ● | |
| Insertion Torque of 1.5mm VA Locking Screws per ASTM F543 | |
| ● | |
| Literature has been provided to support the revision in indications, including the | |
| addition of the adolescent population. | |
| The same technologies are used across the subject and predicate systems through | |
| features such as Combi-holes, limited contact profiles, variable and standard locking | |
| technology, anatomic contours, and similar size ranges. Based on the presented | |
| comparisons and discussions, the subject DePuy Synthes Variable Angle Locking | |
| Hand System does not raise any new issues of safety and efficacy. |
4