(179 days)
Not Found
No
The summary describes a system of bone plates and screws for surgical fixation and fusion, with no mention of AI or ML technology in the device description, intended use, or performance studies.
Yes.
The device is intended for the treatment of various orthopedic conditions, including fracture fixation, osteotomies, reconstruction, revision surgery, and arthrodesis, which directly address a disease or condition.
No
This device is intended for the treatment of fracture fixation, osteotomies, reconstruction, revision surgery, and arthrodesis, and consists of bone plates and screws. These are therapeutic interventions, not diagnostic ones.
No
The device description explicitly states it consists of bone plates and bone screws, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "treatment of fracture fixation, osteotomies... reconstruction, revision surgery and arthrodesis of small bones in the upper and lower extremities." This describes a surgical implant used in vivo (within the body) for structural support and fusion.
- Device Description: The description details "bone plates and bone screws" made of titanium alloy, used for "surgical fusion or arthrodesis between two bone segments." This further confirms its role as a surgical implant.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such tests.
- Performance Studies: The performance studies listed are mechanical testing and bacterial endotoxin testing, which are relevant to the safety and function of a surgical implant, not an IVD.
Therefore, based on the provided information, the AlignMATE™ Lapidus Arthrodesis System is a surgical implant, not an In Vitro Diagnostic device.
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 (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The AlignMATE™ Lapidus Arthrodesis System consists of bone plates and bone screws (locking, non-locking and interfragmentary), which are intended to be used for surgical fusion or arthrodesis between two bone segments (ex. 1st metatarsalcuneiform fusion as in a Lapidus procedure). All implant components are manufactured from implant grade titanium alloy.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
In support of this submission, the following non-clinical tests and/or analysis were performed for the Subject Device:
- Device Comparative Analysis
- Mechanical Testing Bending, Torsional, Insertion/ Removal, Pullout Tests per . ASTM Standards
- . A Kinetic Chromogenic LAL Test for Devices which meets the standard limit of 0.5 EU/mL or 20 EU/ Device per United States Pharmacopeia (USP) Chapter Bacterial Endotoxins Test, USP Chapter Transfusion and Infusion Assemblies and Similar Medical Devices, and AAMI ST72:2002/R2010, Bacterial Endotoxins—Test Methodologies, Routine Monitoring, and Alternatives to Batch Testing.
The results have demonstrated that the AlignMATE™ Lapidus Arthrodesis System 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.
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other, forming a single abstract shape.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 21, 2017
Arthrosurface, Inc. Phani Puppala Quality Coordinator 28 Forge Parkway Franklin, Massachusetts 02038
Re: K162391
Trade/Device Name: AlignMATE™ Lapidus Arthrodesis 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: January 25, 2017 Received: January 26, 2017
Dear Mr. Puppala:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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 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" (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 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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement Section 4
510(k) Number (if known): K162391
Device Name: AlignMATE™ Lapidus Arthrodesis 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 | √ |
|---|---|
| (Part 21 CFR 801 Subpart D) |
AND/OR
| Over-The-Counter Use | |
|---|---|
| (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)
Page 1 of 1
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Section 5 510(k) Summary
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: | Phani Puppala
Quality Coordinator
Tel: 508.520.3003
Fax: 508.528.4604
ppuppala@arthrosurface.com |
| Establishment Registration
Number: | 3004154314 |
| Date of Preparation: | February 16, 2017 |
| Confidentiality: | Reference Section 3 |
| Proprietary Name: | AlignMATE™ Lapidus Arthrodesis System |
| Common Name: | Bone Plates and Screws |
| Device: | Plate, Fixation, Bone
Screw, Fixation, Bone |
| 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: | Class II |
| Review Panel: | Orthopedic |
| Product Code: | HRS: HWC |
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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 AlignMATE™ Lapidus Arthrodesis System consists of bone plates and bone screws (locking, non-locking and interfragmentary), which are intended to be used for surgical fusion or arthrodesis between two bone segments (ex. 1st metatarsalcuneiform fusion as in a Lapidus procedure). All implant components are manufactured from implant grade titanium alloy.
Substantial Equivalence Information
Arthrosurface, Inc. demonstrated that, for the purposes of FDA's regulation of medical devices, the AlignMATE™ Lapidus Arthrodesis System is substantially equivalent in indications and design principles to the following predicate and/or reference devices, which have been previously cleared by the FDA:
Primary Predicate Pinit® Small Bone Fusion System (K140617, Cleared on 04/25/2014)
Additional Predicate(s)
CheckMate® Metatarso-Phalangeal (MTP) Arthrodesis System (K113762, Cleared on 02/06/2012)
The fundamental scientific technology of the proposed device has not changed relative to the predicate devices.
- Has the same Indications for Use, ●
- Uses the same operating principle,
- ls manufactured using common orthopedic implant materials Titanium alloy, ●
- Utilizes the same instrumentation for proper placement,
- Is packaged and sterilized using the same materials and processes.
5
In support of this submission, the following non-clinical tests and/or analysis were performed for the Subject Device:
- Device Comparative Analysis
- Mechanical Testing Bending, Torsional, Insertion/ Removal, Pullout Tests per . ASTM Standards
- . A Kinetic Chromogenic LAL Test for Devices which meets the standard limit of 0.5 EU/mL or 20 EU/ Device per United States Pharmacopeia (USP) Chapter Bacterial Endotoxins Test, USP Chapter Transfusion and Infusion Assemblies and Similar Medical Devices, and AAMI ST72:2002/R2010, Bacterial Endotoxins—Test Methodologies, Routine Monitoring, and Alternatives to Batch Testing.
The results have demonstrated that the AlignMATE™ Lapidus Arthrodesis System is substantially equivalent to the predicate devices.