(125 days)
Not Found
No
The summary describes a mechanical implant system and its performance testing, with no mention of software, algorithms, or AI/ML concepts.
No
The device is a plating system intended for fixation of fractures and dislocations, which is a structural repair and not directly therapeutic in nature.
No
The device, the Acumed Clavicle Hook Plating System, is described as intended for fixation of fractures, osteotomies, mal-unions, non-unions, and dislocations. It contains plates, screws, and instrumentation for surgical fixation, not for diagnosing medical conditions.
No
The device description clearly states it contains physical components like plates, screws, and instrumentation made from Titanium Alloy, and the performance studies focus on mechanical testing of these hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the fixation of bone fractures and joint dislocations. This is a surgical implant used in vivo (within the body).
- Device Description: The description details plates and screws made of titanium alloy, which are typical materials for surgical implants.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the body (like blood, urine, tissue), detecting specific substances, or providing diagnostic information based on laboratory tests.
IVD devices are used to examine specimens obtained from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical tool and implant used to physically stabilize bone and joint structures.
N/A
Intended Use / Indications for Use
The Acumed Clavicle Hook Plating System is intended for fixation of lateral clavicle fractures, osteotomies, mal-unions, non-unions and dislocations of the acromioclavicular joint.
Product codes
HRS, HWC
Device Description
The Acumed Clavicle Hook Plating system contains pre-contoured hook plates, 3.5mm locking screws and other typical instrumentation for AC joint reduction or distal clavicle fragments cases. All implants are manufactured from Titanium Alloy (Ti 6AL-4V) per ASTM F136 and are provided both sterile and non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lateral clavicle, acromioclavicular joint
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
The subject plate performance was evaluated by performing static 4-point bending tests in accordance with ASTM F382-17 Annex A1, as well as dynamic 4-point bending tests per ASTM F382-17 Annex A2 to ensure that the design features met the required mechanical strength criteria for their intended use. Within these tests, the performance of the subject device Hook Plate) was compared to that of the reference device (Acumed Narrow-Profile Clavicle Plate) and based on the results, it was concluded that the subject and reference devices are comparable in performance specifically for the intended use, hence was proven to be safe and effective for the indication.
The subject screws were evaluated for their torsion torque, and pullout strength per Annex A1, Annex A2, and Annex A3 of ASTM F543-17, and based on the acceptance criteria developed from the FDA Guidance "Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway" issued December 11, 2020. Based on the results, the subject screws were found to be adequate in performance specifically for the intended safe and effective for the indication.
Clinical testing was not required to support substantial equivalence. (Not Applicable)
Based on the results of the nonclinical bench testibed above, it was concluded that the subject, predicate and reference devices are equivalent in performance specifically for the intented use, hence was proven to be safe and effective for the indication.
Key Metrics
Not Found
Predicate Device(s)
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
July 15, 2021
Image /page/0/Picture/1 description: The image shows 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 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.
Acumed LLC Janki Bhatt Regulatory Specialist 3 5885 NE Cornelius Pass Road Hillsboro, Oregon 97124
Re: K210750
Trade/Device Name: Acumed Clavicle Hook Plating 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: June 14, 2021 Received: June 16, 2021
Dear Janki Bhatt:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For: Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair, and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Submission Number (if known)
Device Name
Acumed Clavicle Hook Plating System
Indications for Use (Describe)
The Acumed Clavicle Hook Plating System is intended for fixation of lateral clavicle fractures, osteotomies, mal-unions, non-unions and dislocations of the acromioclavicular joint.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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K210750 (Page 1 of 2)
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(5)
| 510(k) Summary | |
|---|---|
| Contact Details | 21 CFR 807.92(a)(1) |
| Applicant Name | Acumed LLC |
| Applicant Address | 5885 NE Cornelius Pass Road Hillsboro OR 97124 United States of |
| America | |
| Applicant Contact Telephone | (503) 718-8753 |
| Applicant Contact | Ms. Janki Bhatt |
| Applicant Contact Email | janki.bhatt@acumed.net |
| Device Name | 21 CFR 807.92(a)(2) |
| Device Trade Name | Acumed Clavicle Hook Plating System |
| Common Name | Single/multiple component metallic bone fixation appliances and accessor+ |
| Classification Name | Plate, Fixation, Bone and Screw, Fixation, Bone |
| Regulation Number | 888.3030 and 888.3040 |
| Product Code | HRS and HWC |
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) Product Code |
| K140259 | VariAx Clavicle Hook Plate HRS |
| K112111 | Acumed Locking Clavicle Plating System HRS |
| K140259 | VariAx Clavicle Hook Plate (Screws) HWC |
| Device Description Summary | 21 CFR 807.92(a)(4) |
Device Description Summary
The Acumed Clavicle Hook Plates are intended for fixation of lateral clavicle fractures, osteotomies, mal-unions and dislocations of the acromioclavicular joint. This Traditional 510(k) is intended to introduce the Acumed Clavicle Hook Plates to the currently marketed Acumed Locking System (K11211). The subject device is being compared to the predicate device, the Stryker Variax Hook Plate (K140259).
The Acumed Clavicle Hook Plating system contains pre-contoured hook plates, 3.5mm locking screws and other typical instrumentation for AC joint reduction or distal clavice fragments cases. All implants are manufactured from Titanium Alloy (Ti 6AL-4V) per ASTM F136 and are provided both sterile and non-sterile.
Intended Use/Indications for Use
The Acumed Clavicle Hook Plating System is intended for fixation of lateral clavicle fractures, mal-unions and dislocations of the acromioclavicular joint.
Indications for Use Comparison
The subject device, the Acumed Clavice Hook Plating System, has the predicate device, the Stryker Variax
4
Hook Plate. The basis of substantial equivalence for the similarities in intended use, material, technology, operating principles, anatomical site for implantation, screw types/diameters and design as the predicate and subject devices are rigidly fixed to the superior surface of the distal clavich is positioned below the acromion to provide buttress support to the acromioclavicular joint.
Technological Comparison
21 CFR 807.92(a)(6)
The subject device plates incorporate the same technological characteristics such as design, materials and principles of operation as the predicate device. Both subject and predicate plates are offered in Left and Right specific options for anatomic fit and use locking and non-locking screws to provide rigid fixation, strength, and construct stability. The Acumed Clavice is made of similar material to the Stryker Variax Clavicle Hook Plate, titanium alloy (Ti-6Al-4V per ASTM F136). The plate lengths, widths, and thicknesses of the subject and predicate devices are equivalent. The subject and predicate devices are similar as well.
The subject device screws have similar technology and operating principles as the predicate device screws. Both the Acumed Clavice Hook Plating System Screws and the Stryker Variax Clavicle Hook Plate screws are locking screws that provide rigid fixation, strength, and construct stability. The subject device screws are material as the predicate screws, i.e., titanium alloy (Ti-6Al-4V per ASTM F136). The subject and predicate device screws both consist of headed screws. The screw diameters and lengths available for the subject device screws are similar to the predicate device screws. The subject device locking screws are considered fixed angle, vs the predicate device screws are locking screws, however both screws accomplish the same functional result of a locking plate-screw considered similar in technology.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
The subject plate performance was evaluated by performing static 4-point bending tests in accordance with ASTM F382-17 Annex A1, as well as dynamic 4-point bending tests per ASTM F382-17 Annex A2 to ensure that the design features met the required mechanical strength criteria for their intended use. Within these tests, the performance of the subject device Hook Plate) was compared to that of the reference device (Acumed Narrow-Profile Clavicle Plate) and based on the results, it was concluded that the subject and reference devices are comparable in performance specifically for the intended use, hence was proven to be safe and effective for the indication.
The subject screws were evaluated for their torsion torque, and pullout strength per Annex A1, Annex A2, and Annex A3 of ASTM F543-17, and based on the acceptance criteria developed from the FDA Guidance "Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway" issued December 11, 2020. Based on the results, the subject screws were found to be adequate in performance specifically for the intended safe and effective for the indication.
Clinical testing was not required to support substantial equivalence. (Not Applicable)
Based on the results of the nonclinical bench testibed above, it was concluded that the subject, predicate and reference devices are equivalent in performance specifically for the intented use, hence was proven to be safe and effective for the indication.