(129 days)
No
The description focuses on the mechanical properties and design of a bone fusion plate and screws, with no mention of AI or ML.
Yes
The device is intended for fusion of bones in the wrist, which is a therapeutic intervention.
No
This device is described as a plate system for orthopedic fusion, specifically for the trapezium and first metacarpal. Its function is to physically connect and stabilize bones for fusion, not to diagnose a condition.
No
The device description clearly describes a physical implant (plate and screws) made of titanium, intended for surgical fusion. It does not mention any software component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the fusion of bones (trapezium and first metacarpal) in the wrist/hand. This is a surgical procedure performed on the body.
- Device Description: The device is a plate and screws made of titanium, designed to be implanted in the body to stabilize bones.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the body to provide information about a person's health. This device does not perform any such analysis of specimens.
The APTUS® CMC-I Fusion Plate System is a surgical implant used for orthopedic procedures.
N/A
Intended Use / Indications for Use
The APTUS® CMC-I Fusion Plate System is intended to be used for fusion of the trapezium with the first metacarpal.
Product codes (comma separated list FDA assigned to the subject device)
HRS
Device Description
The subject device plate has an anatomical design appropriate for both the left and right wrist. The plate has a uniform thickness of 1.3 mm and has overall dimensions of approximately 35 mm x 13 mm, before bending to conform to the hand anatomy. The screw holes of the plate are designed to accommodate appropriately sized bone screws presently marketed as part of the APTUS® System and previously cleared under K051567. The subject device plate is compatible with 2.0 mm diameter screws, and is used with TriLock locking screws and cortical (nonlocking) screws. The subject device plate is made of unalloyed titanium conforming to ASTM F67.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
trapezium with the first metacarpal (wrist/hand)
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)
Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence include: biocompatibility (referenced from K051567), mechanical testing (according to ASTM F382), and comparative dynamic testing in a simulated fracture model. Clinical data were not provided in this submission.
Performance data provided to demonstrate substantial equivalence included four-point bend testing (according to ASTM F382), and comparative dynamic testing in a simulated fracture model.
The subject device plates and the primary predicate device plates have intended use, have similar technological characteristics, encompass a similar range of physical dimensions appropriate to the anatomy and are made of the same material. The subject device and reference predicate device K051567 are packaged in similar materials and are to be sterilized by the end-user using similar methods. Performance data demonstrated the subject device plates to be substantially equivalent to K062498.
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.
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 24, 2018
Medartis AG % Kevin A. Thomas, Ph.D. Vice President and Director of Regulatory Affairs PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130
Re: K181009
Trade/Device Name: APTUS CMC-I Fusion Plate 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 Dated: July 23, 2018 Received: July 24, 2018
Dear Kevin A. Thomas, Ph.D .:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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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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
APTUS® CMC-I Fusion Plate System
Indications for Use (Describe)
The APTUS® CMC-I Fusion Plate System is intended to be used for fusion of the trapezium with the first metacarpal.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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510(k) Summary
Medartis AG
APTUS® CMC-I Fusion Plate System
April 17, 2018
ADMINISTRATIVE INFORMATION
| Manufacturer Name | Medartis AG
Hochbergerstrasse 60E
CH-4057 Basel, Switzerland |
|-------------------|--------------------------------------------------------------------|
| | Telephone: +41 61 633 34 34
Fax: +41 61 633 34 00 |
| Official Contact | Andrea Schweizer
Head of Quality Management |
| Representative/Consultant | Kevin A. Thomas, PhD |
|---|---|
| Floyd G. Larson, MS, MBA | |
| PaxMed International, LLC | |
| 12264 El Camino Real, Suite 400 | |
| San Diego, CA 92130 | |
| Telephone: | +1-858-792-1235 |
| Fax: | +1-858-792-1236 |
| Email: | kthomas@paxmed.com |
| flarson@paxmed.com |
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name | APTUS® CMC-I Fusion Plate System |
|---|---|
| Common Name | Plate, fixation, bone |
| Classification Name | Single/multiple component metallic bone fixation appliance |
| and accessories | |
| Classification Regulation | 21 CFR 888.3030 |
| Product Code | HRS |
| Classification Panel | Orthopedic Products Panel |
| Reviewing Branch | Joint Fixation Devices Branch Two (JFDB2) |
PREDICATE DEVICE INFORMATION
The primary predicate device is K062498, Profyle® System, Howmedica Osteonics Corporation. The reference predicate device is K051567, APTUS® Titanium System, Medartis, Inc.
INDICATIONS FOR USE
The APTUS® CMC-I Fusion Plate System is intended to be used for fusion of the trapezium with the first metacarpal.
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SUBJECT DEVICE DESCRIPTION
The subject device plate has an anatomical design appropriate for both the left and right wrist. The plate has a uniform thickness of 1.3 mm and has overall dimensions of approximately 35 mm x 13 mm, before bending to conform to the hand anatomy. The screw holes of the plate are designed to accommodate appropriately sized bone screws presently marketed as part of the APTUS® System and previously cleared under K051567. The subject device plate is compatible with 2.0 mm diameter screws, and is used with TriLock locking screws and cortical (nonlocking) screws. The subject device plate is made of unalloyed titanium conforming to ASTM F67.
PERFORMANCE DATA
Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence include: biocompatibility (referenced from K051567), mechanical testing (according to ASTM F382), and comparative dynamic testing in a simulated fracture model. Clinical data were not provided in this submission.
EQUIVALENCE TO MARKETED DEVICE
Medartis AG submits the information in this Premarket Notification to demonstrate that, for the purposes of FDA's regulation of medical devices, the subject device is substantially equivalent in indications and design principles to the following legally marketed predicate devices:
K062498, Profyle® System, Howmedica Osteonics Corporation; and
K051567, APTUS® Titanium System, Medartis, Inc.
A comparison of the technological characteristics of the subject device and the primary predicate device K062498 is provided in the following table.
| Subject Device | Primary Predicate Device | |
|---|---|---|
| Comparison | APTUS® CMC-I Fusion Plate System | |
| Medartis AG | K062498 | |
| Profyle® System | ||
| Howmedica Osteonics Corporation | ||
| Indications for Use | ||
| Statement | The APTUS® CMC-I Fusion Plate System is intended to | |
| be used for fusion of the trapezium with the first | ||
| metacarpal. | The Profyle® System is intended for use in internal | |
| fixation of the bones of hand and wrist. Examples of | ||
| these procedures may include but are not limited to | ||
| replantation, lag screw techniques, joint fusions, | ||
| corrective osteotomies, and the treatment of fractures. | ||
| Device Characteristics | ||
| Plate Designs | Anatomic plate design | |
| One size | ||
| Single design for right and left hand-wrist; | ||
| Screw holes accommodate conventional (cortex) and | ||
| locking screws | Anatomic plate designs | |
| Multiple sizes | ||
| Multiple designs | ||
| Screw holes accommodate conventional (cortex) and | ||
| locking screws | ||
| Plate Overall Dimensions | ||
| (Approximate) | 13 mm width x 35 mm length | Various |
| Plate Thickness | Uniform thickness, 1.3 mm | Uniform thickness, range from 0.55 mm – 1.5 mm |
| Plate Material | Unalloyed titanium, grade 4 (ASTM F67) | Unalloyed titanium, grade 2 |
| Screw Designs | Previously cleared: | |
| Locking screws: cortical thread form, double thread, | ||
| self-tapping, fully threaded |
Non-locking screws: cortical thread form, single thread,
self-tapping, fully threaded
Cannulated screws: cortical thread form, single thread,
self-tapping, partially threaded, cannulated | Cortical thread form
Self-tapping, fully threaded
Conventional (non-locking) and locking |
| Screw Diameter | Previously cleared:
2.0 mm (locking and non-locking)
3.0 mm (cannulated) | 1.2 mm to 2.5 mm |
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| Subject Device | Primary Predicate Device | |
|---|---|---|
| Screw Length | Previously cleared: | |
| 8 mm to 20 mm (conventional and locking) | ||
| 18 mm to 32 mm (cannulated) | 6 mm to 26 mm | |
| Screw Material | Previously cleared: | |
| Ti-6Al-4V alloy, ASTM F136 | Ti-6Al-4V alloy |
The subject device, the primary predicate device K062498, and reference predicate device K051567 have the same intended use for internal fixation of the bones of the hand and wrist, and have the same technological characteristics. The subject device and the plates from both predicate devices (K062498 and K051567) are fabricated from unalloyed titanium. The subject device and the reference predicate device K051567 have similar design characteristics, including the design of screw holes to accommodate locking and non-locking screws. The subject device and both predicate devices (plates) encompass a similar range of physical dimensions (overall width, length, and thickness). The subject device plates are compatible exclusively with screws from the reference predicate device K051567.
The differences between the subject device and primary predicate device K062498 are slight variations in the design of the plates and compatible screws. The differences between the subject device and reference predicate device K051567 plates are the specific design configurations and dimensions. These slight differences among the subject device and predicate devices do not raise of safety or efficacy.
The final finished subject device is manufactured in the same facilities using identical materials and identical manufacturing processes as used for the previously cleared reference predicate device components cleared in K051567, and therefore are substantially equivalent to the reference predicate device regarding biocompatibility. The subject device and reference predicate device K051567 components are packaged using the same materials, and are to be sterilized by the same methods.
The Indications for Use Statement for the subject device is similar to that of the primary predicate device K062498. The slight differences in wording do not affect the intended use for internal fixation of the hand and wrist.
Performance data provided to demonstrate substantial equivalence included four-point bend testing (according to ASTM F382), and comparative dynamic testing in a simulated fracture model.
CONCLUSION
The subject device plates and the primary predicate device plates have intended use, have similar technological characteristics, encompass a similar range of physical dimensions appropriate to the anatomy and are made of the same material. The subject device and reference predicate device K051567 are packaged in similar materials and are to be sterilized by the end-user using similar methods. Performance data demonstrated the subject device plates to be substantially equivalent to K062498.
The data included in this submission demonstrate substantial equivalence to the predicate devices K062498 and K051567.