(45 days)
Not Found
No
The device description and performance studies focus on mechanical properties and design modifications of bone plates and screws, with no mention of AI or ML.
Yes
The device aids in the treatment of various orthopedic conditions such as fracture fixation, osteotomies, reconstruction, revision surgery, and arthrodesis, which are medical treatments.
No
Explanation: The device is intended for treatment (fracture fixation, osteotomies, reconstruction, etc.) and not for diagnosing a condition.
No
The device description clearly outlines physical components (bone plates, bone screws) made from implant-grade stainless steel, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological state, state of health, or disease or congenital abnormality.
- Device Description and Intended Use: The provided text clearly describes a system of bone plates and screws intended for the surgical fixation of fractures and other bone procedures in the upper and lower extremities. This is a surgical implant used directly on the patient's body, not for testing specimens outside the body.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory tests.
Therefore, based on the provided information, the Pinit™ Small Bone Fusion System is a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Intended for the treatment of fracture fixation, osteotomies (ex. Akin, Chevron, Scarf, Weil), reconstruction, revision surgery and arthrodesis of small bones in the upper and lower extremities.
Product codes
HRS, HWC
Device Description
The Pinit™ Small Bone Fusion System consists of 2-hole bone plates made available in three length options and two thickness options, and 2.0 mm and 2.7 mm diameter bone screws having lengths varying from 8 mm to 24 mm. The bone plate is pre-assembled with a suture loop intended to provide a traction force required to achieve compression between bone seaments. The bone screws have a snap-off feature designed to work with the plates and/or as standalone bone fixation fasteners. The bone plates and screws are manufactured from implant grade stainless steel.
The only modification made in this submission was the addition of bone plates having the same design profile with a different thickness. Also, the Trade/Proprietary Name was changed from CheckMate™ to Pinit™.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Small bones in the upper and lower extremities.
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
In support of this submission, the following non-clinical tests and analysis have been performed for the Subject Device:
- Bending Moment/Flexural Strength Testing.
- Engineering Analyses/Calculations using Bending Theory
The results have demonstrated that the Arthrosurface Pinit™ Implants are substantially equivalent to the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
CheckMate™ Small Bone Fusion System (K122334), Aptus® 1.5 TriLock (K102537), Arthrex Small Fragment Plates and Screws (K040907)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K140617
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Section 5 510(k) Summary
Pinit™ Small Bone Fusion System Special 510(k): Device Modification
510(k) Owner:
Arthrosurface, Inc. 28 Forge Parkway Franklin, MA 02038 Tel: 508.520.3003 Fax: 508.528.4604
Contact:
Dawn Wilson VP, Quality & Regulatory 508.520.3003 Tel: 508.528.4604 Fax: dwilson@arthrosurface.com
| Establishment Registration
| Number: | 3004154314 |
|---|---|
| Date of Preparation: | March 25, 2014 |
| Confidentiality: | Reference Section 3 |
| Proprietary Name: | Pinit TM Small Bone Fusion System |
| Common Name: | Bone Plates and Screws |
| Regulation Description: | Single/multiple component metallic bone |
| fixation appliances and accessories. | |
| Smooth or threaded metallic bone fixation | |
| fastener | |
| Regulation Number: | 888.3030 |
| 888.3040 |
Device Class:
1
Review Panel:
Orthopedic
Product Code:
HRS: HWC
Intended Use
Intended for the treatment of fracture fixation, osteotomies (ex. Akin, Chevron, Scarf, Weil), reconstruction, revision surgery and arthrodesis of small bones in the upper and lower extremities.
Device Description
The Pinit™ Small Bone Fusion System consists of 2-hole bone plates made available in three length options and two thickness options, and 2.0 mm and 2.7 mm diameter bone screws having lengths varying from 8 mm to 24 mm. The bone plate is pre-assembled with a suture loop intended to provide a traction force required to achieve compression between bone seaments. The bone screws have a snap-off feature designed to work with the plates and/or as standalone bone fixation fasteners. The bone plates and screws are manufactured from implant grade stainless steel.
The only modification made in this submission was the addition of bone plates having the same design profile with a different thickness. Also, the Trade/Proprietary Name was changed from CheckMate™ to Pinit™.
Substantial Equivalence Information
Arthrosurface, Inc. demonstrated that, for the purposes of FDA's regulation of medical devices, the Pinit™ Small Bone Fusion System is substantially equivalent in indications and design principles to the following predicate devices, which have been previously cleared by the FDA:
CheckMate™ Small Bone Fusion System (K122334, Cleared on 11/28/2012) Aptus® 1.5 TriLock (K102537, Cleared on 12/10/2010) Arthrex Small Fragment Plates and Screws (K040907, Cleared on 07/01/2004)
The fundamental scientific technology of the proposed device has not changed relative to the predicate device (K122334).
- Have the same Indications for Use, .
2
- Use the same operating principle, .
- Have the same design profile, .
- Manufactured using the same material, .
- Have the same shelf life, .
- Are packaged and sterilized using the same materials and processes. .
In support of this submission, the following non-clinical tests and analysis have been performed for the Subject Device:
- Bending Moment/Flexural Strength Testing .
- . Engineering Analyses/Calculations using Bending Theory
The results have demonstrated that the Arthrosurface Pinit™ Implants are substantially equivalent to the predicate devices.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with three stylized wing-like shapes.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 25, 2014
Arthrosurface. Incorporated Ms. Dawn J. Wilson Vice President, Quality & Regulatory 28 Forge Parkway Franklin, Massachusetts 02038
Re: K140617
Trade/Device Name: Pinit™ Small Bone Fusion System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component bone fixation appliances and accessories Regulatory Class: Class 11 Product Code: HRS, HWC Dated: March 25, 2014 Received: March 26, 2014
Dear Ms. Wilson:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
Page 2 - Ms. Dawn J. Wilson
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 Small Manufacturers. International and Consumer Assistance at its tollfree 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" (21 CFR 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.
Ronald P. Jean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Section 4 Indications for Use Statement 1 - 1 - 1 - 1 - 1 -
510(k) Number (if known): _ K140617
Device Name: Pinit™ Small Bone Fusion System
Indications for Use:
Intended for the treatment of fracture fixation, osteotomies (ex. Akin, Chevron, Scarf, Weil), reconstruction, revision surgery and arthrodesis of small bones in the upper and lower extremities.
Prescription Use V (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Limin Sun-S 2014.04.25 14:45:31 -04'00'
(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K140617
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