(81 days)
Not Found
No
The document describes a mechanical implant system for bone fusion and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is indicated for fusion of small bones of the hand to address conditions causing pain and/or loss of function, such as various forms of arthritis and carpal instability, which are therapeutic goals.
No
The device is a surgical implant (Intercarpal Fusion System) used to fuse small bones of the hand for conditions like arthritis and carpal instability. It is a treatment device, not for diagnosis.
No
The device description clearly states it is a "2.4mm VA-LCP Intercarpal Fusion System" featuring "low profile circular plates" and "K-wire holes," which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided information clearly describes a surgical implant (plates and screws) intended for the fusion of bones in the hand. This is a therapeutic device used in the body, not a diagnostic device used on specimens taken from the body.
The device's purpose is to provide structural support and stability for bone fusion, which is a surgical treatment, not a diagnostic test.
N/A
Intended Use / Indications for Use
The 2.4mm VA-LCP Intercarpal Fusion System is indicated for fusion of small bones of the hand including: hamate, capitate, lunate, and triquetrum, for the revision of failed partial wrist fusions, and is indicated for use in patients suffering pain and/or loss of function due to:
- -Osteoarthritis
- -Rheumatoid arthritis
- -Post-traumatic or degenerative wrist arthritis
- -Carpal instability
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The 2.4mm VA-LCP Intercarpal Fusion System features low profile circular plates. The plates are available in two sizes: ø15mm (6 holes) and øl 7mm (7 holes). The plates each feature variable angle locking technology. The plates also feature K-wire holes for positioning and temporary fixation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Small bones of the hand including: hamate, capitate, lunate, and triquetrum, wrist
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)
Functional and mechanical testing demonstrates the comparable mechanical & functional properties of the subject 2.4mm VA-LCP Intercarpal Fusion System to the predicate devices. In support of this submission 1-point bending was performed.
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
§ 888.3030 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.
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Image /page/0/Picture/0 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. To the right of the word is a small "R" in a circle, indicating a registered trademark.
K103243
| 3.0 | 510(k) Summary |
|---|---|
| Date Prepared: Jan 11, 2011 | |
| Page 1 of 1 | |
| Sponsor: | |
| Synthes (USA) | |
| Christopher Hack, Esq. | |
| 1301 Goshen Parkway | |
| West Chester, PA 19380 | |
| (610) 719-6940 | |
| JAN 21 2011 | |
| Device Name: | |
| 2.4mm VA-LCP Intercarpal Fusion System | |
| Classification: | |
| Class II, §888.3030 - Single/multiple component metallic bone | |
| fixation appliances and accessories, HRS | |
| Class II, §888.3040 -- Smooth or threaded metallic bone fixation | |
| fastener, HWC | |
| Predicate Device: | |
| KMI - Wrist Fusion System (K990094) | |
| KMI - Wrist Fusion System (K991873) | |
| Acumed - Hub Cap Limited Wrist Fusion Plate (K021321) | |
| Device Description: | |
| The 2.4mm VA-LCP Intercarpal Fusion System features low | |
| profile circular plates. The plates are available in two sizes: | |
| ø15mm (6 holes) and øl 7mm (7 holes). The plates each feature | |
| variable angle locking technology. The plates also feature K-wire | |
| holes for positioning and temporary fixation. | |
| Intended Use: | |
| The 2.4mm VA-LCP Intercarpal Fusion System is indicated for | |
| fusion of small bones of the hand including: hamate, capitate, | |
| lunate, and triquetrum, for the revision of failed partial wrist | |
| fusions, and is indicated for use in patients suffering pain and/or | |
| loss of function due to: | |
| -Osteoarthritis | |
| -Rheumatoid arthritis | |
| -Post-traumatic or degenerative wrist arthritis | |
| -Carpal instability | |
| Substantial | |
| Equivalence: | |
| The features of the subject components are substantially equivalent | |
| to the predicate devices based on similarities in intended use and | |
| design. Engineering rationale 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. | |
| The subject and predicate devices are made from stainless steel and | |
| titanium alloy (TAN). Functional and mechanical testing | |
| demonstrates the comparable mechanical & functional properties of | |
| the subject 2.4mm VA-LCP Intercarpal Fusion System to the | |
| predicate devices. In support of this submission 1-point bending | |
| was performed. |
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is an emblem that resembles a stylized eagle or bird in flight. The emblem is composed of three curved lines that form the body and wings of the bird, with a tail extending downwards.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Synthes (USA) % Mr. Christopher Hack, Esq. 1301 Goshen Parkway West Chester, PA 19380
Re: K103243
Trade/Device Name: Synthes (USA) 2.4mm VA-LCP Intercarpal Fusion System Regulation Number: 21 CFR 888.3030
Regulation Name: Single/multiple component metallic bone fixation appliances and accessories
JAN 2 1 2011
Regulatory Class: II
Product Code: HRS. HWC Dated: October 29, 2010 Received: November 16, 2010
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. 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
2
Page 2 - Mr. Christopher Hack, Esq.
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 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/ReportalProblem/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,
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/3/Picture/0 description: The image shows the logo for Synthes. The logo consists of a circular symbol on the left, followed by the word "SYNTHES" in bold, sans-serif font. The circular symbol contains a stylized image of a bone or joint, possibly representing the company's focus on medical devices and orthopedic solutions. The registered trademark symbol is located on the upper right of the word "SYNTHES".
2.0 Indications for Use
K103243 510(k) Number (if known):
Synthes (USA) 2.4mm VA-LCP Intercarpal Fusion System Device Name:
Indications for Use:
The 2.4mm VA-LCP Intercarpal Fusion System is indicated for fusion of small bones of the hand including: hamate, capitate, lunate, and triquetrum, for the revision of failed partial wrist fusions, and is indicated for use in patients suffering pain and/or loss of function due to:
- -Osteoarthritis -Rheumatoid arthritis -Post-traumatic or degenerative wrist arthritis -Carpal instability
Prescription Use X (Per 21 CFR 801.109)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
tor m helkerson
(Division Sign-Oft) (Division Sign-Off, Orthopedic, Division of Suits and Restorative Devices
51.0(k) Number K10322