(116 days)
Not Found
No
The summary describes a mechanical screw system and its associated instrumentation, with no mention of software, algorithms, or any technology related to AI or ML.
No
The device is described as a screw system intended for fixation of fractures and non-unions, arthrodesis, bunionectomies, and osteotomies of small bones. These are surgical interventions rather than a therapeutic treatment in the sense of healing or alleviating a disease or condition without direct surgical or invasive manipulation. It acts as a mechanical support/fixation device.
No
This device is a screw system intended for fixation of fractures and non-unions of small bones and joints. It is a treatment device, not a diagnostic one.
No
The device description explicitly states it includes physical components such as titanium screws and single-use instrumentation (guide wire, drill, driver). It also describes mechanical performance testing (torque, torsion, pullout), which is characteristic of hardware devices, not software.
Based on the provided information, the Haymaker® Screw System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- The Haymaker® Screw System is a surgical implant used for the fixation of bones and joints. Its intended use is directly on the patient's body during a surgical procedure, not for testing biological samples.
The description clearly outlines a medical device used for surgical intervention, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Haymaker® Screw System is intended for fixation of intra-articular and extra-articular fractures and non-unions of small bones and small bone fragments; arthrodesis of small joints; bunionectomies and osteotomies, including scaphoid and other carpal bones, metacarpals, tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
The Haymaker® System includes type-II anodized fully threaded titanium (Ti-6Al-4V ELI per ASTM F136) screws which provides a dual thread at the proximal end of the screw, increasing engagement with the head and neck of the metacarpal or other small bones. A tapered design is intended to allow the screw to fit more comfortably through the narrowing of an intramedullary canal. Multiple lengths from 25 mm at 03.6 mm or Ø4.5 mm in diameter are offered for treatment of various shapes and sizes of small bones. Single use supplemental instrumentation is provided sterile packed, consisting of a guide wire, cannulated drill, and T-10 cannulated driver.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intra-articular and extra-articular fractures and non-unions of small bones and small bone fragments; arthrodesis of small joints; bunionectomies and osteotomies, including scaphoid and other carpal bones, metacarpals, tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.
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)
The Haymaker® Screw System has been tested in the following test modes:
- Static Driving and Removal Torque per ASTM F543
- Torsional Properties per ASTM F543
- Axial Pullout per ASTM F543
The results of this non-clinical testing show that the strength of the Haymaker® Screw System is sufficient for its intended use and is substantially equivalent to legally marketed 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
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted 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 and 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.
January 10, 2023
OrthoCircle Spine d.b.a. OC Medical Devices % Nathan Wright Engineer & Regulatory Specialist Empirical Technologies 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K222799
Trade/Device Name: Haymaker® Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: December 12, 2022 Received: December 12, 2022
Dear Nathan Wright:
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.
1
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 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 medical devices and radiation-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.
Shumaya Ali -S
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
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Submission Number (if known)
Device Name
Haymaker® Screw System
Indications for Use (Describe)
The Haymaker® Screw System is intended for fixation of intra-articular and extra-articular fractures and non-unions of small bones and small bone fragments; arthrodesis of small joints; bunionectomies and osteotomies, including scaphoid and other carpal bones, metacarpals, tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.
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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3
K222799 - 510(K) SUMMARY
| Submitter's Name: | OrthoCircle Spine D.B.A. OC Medical Devices |
|---|---|
| Submitter's Address: | 15 East Montgomery Crossroads, Suite 3 |
| Savannah, GA 31406 | |
| Submitter's Telephone: | 888-463-5803 |
| Contact Person: | Nathan Wright MS |
| Empirical Technologies | |
| 1-719-351-0248 | |
| nwright@empiricaltech.com | |
| Image: Empirical Technologies Logo | |
| Date Summary was Prepared: | December 12, 2022 |
| Trade or Proprietary Name: | Haymaker® Screw System |
| Common or Usual Name: | Smooth Or Threaded Metallic Bone Fixation Fastener |
| Classification: | Class II per 21 CFR §888.3040 |
| Product Code: | HWC |
| Classification Panel: | Orthopedic |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Haymaker® System includes type-II anodized fully threaded titanium (Ti-6Al-4V ELI per ASTM F136) screws which provides a dual thread at the proximal end of the screw, increasing engagement with the head and neck of the metacarpal or other small bones. A tapered design is intended to allow the screw to fit more comfortably through the narrowing of an intramedullary canal. Multiple lengths from 25 mm at 03.6 mm or Ø4.5 mm in diameter are offered for treatment of various shapes and sizes of small bones. Single use supplemental instrumentation is provided sterile packed, consisting of a guide wire, cannulated drill, and T-10 cannulated driver.
INDICATIONS FOR USE
The Haymaker® Screw System is intended for fixation of intra-articular and extra-articular fractures and nonunions of small bones and small bone fragments; arthrodesis of small joints; bunionectomies, including scaphoid and other carpal bones, metacarpals, tarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.
TECHNOLOGICAL CHARACTERISTICS
The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically, the following characteristics are the same between the subject and predicates:
- Indications for Use
- Materials of manufacture
- Structural support mechanism
- Sizes
Predicate Devices
| 510k
Number | Trade or Proprietary or Model Name | Manufacturer | Product
Code | Predicate
Type |
|----------------|--------------------------------------------------------|-------------------------------|-----------------|-------------------|
| K183603 | Innate Cannulated Screw System | Exsomed Corporation | HWC | Primary |
| K171558 | ExoMed ITN Cannulated Screw System | ExsoMed Holdings Company, LLC | HWC | Additional |
| K172617 | Treace Medical Concepts (TMC) Compression Screw System | Treace Medical Concepts, Inc. | HWC | Additional |
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Performance Data
The Haymaker® Screw System has been tested in the following test modes:
- Static Driving and Removal Torque per ASTM F543 ●
- Torsional Properties per ASTM F543 ●
- Axial Pullout per ASTM F543 ●
The results of this non-clinical testing show that the strength of the Haymaker® Screw System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
CONCLUSION
The overall technology characteristics and mechanical performance data lead to the conclusion that the Haymaker® Screw System is substantially equivalent to the predicate device.