(269 days)
The HammerTube™ System is indicated for fixation of reconstruction and fusion of toes during correction procedures for hammertoe deformity, claw toe deformity, shortening osteotomies of the phalanges and mallet toe deformity as well as revision hammertoe procedures.
The cannulated and solid HammerTube™ implants may be used without any other additional device. The cannulated implants may be used with K-wires for delivery of implants or for the temporary stabilization of nearby joints, such as the metatarsophalangeal joint.
The implantable K-wires are indicated for use in the stabilization and fixation of small bones for use in bone reconstruction, osteotomy, arthrodesis, fracture repair and fixation, appropriate for the size of the joint. Additionally, the implantable K-wires are indicated as guide pins for insertion of instruments and implants in the HammerTube™ System
The HammerTube™ System includes HammerTube™ and K-wire implants. the HammerTube™ is a commercially pure titanium plasma sprayed PEEK cylinder in varying diameters and lengths. The K-wires are stainless steel and double trocar pointed.
This document does not contain information about a study proving that a device meets specific acceptance criteria in the context of AI/ML performance.
The provided text is a 510(k) premarket notification letter from the FDA to Paragon 28 regarding their HammerTube System. It includes:
- Indications for Use: The HammerTube™ System is indicated for fixation of reconstruction and fusion of toes during correction procedures for hammertoe deformity, claw toe deformity, shortening osteotomies of the phalanges, mallet toe deformity, and revision hammertoe procedures. The K-wires are indicated for stabilization and fixation of small bones, as well as guide pins.
- Device Description: The HammerTube™ consists of a commercially pure titanium plasma-sprayed PEEK cylinder. The K-wires are made of stainless steel.
- Performance Data: "Static and dynamic cantilever bending, and static pullout testing was performed." This refers to mechanical testing of the physical device, not an AI/ML algorithm.
- Substantial Equivalence: The FDA determined the device is substantially equivalent to legally marketed predicate devices based on similar indications for use and technological characteristics (performance, basic design, material, and sizes).
Therefore, I cannot provide the requested information regarding acceptance criteria, device performance metrics (such as accuracy, sensitivity, specificity for an algorithm), sample sizes, ground truth establishment, or expert reviews for an AI/ML device, as this document pertains to a physical medical device (HammerTube System) and its mechanical performance and substantial equivalence to predicates.
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March 5, 2018
Paragon 28 % Karen Warden Representative/Consultant BackRoads Consulting, Inc PO Box 566 Chesterland, Ohio 44026-0566
Re: K171715
Trade/Device Name: HammerTube System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HTY Dated: January 22, 2018 Received: January 23, 2018
Dear Karen Warden:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known)
Device Name HammerTube™ System
Indications for Use (Describe)
The HammerTube™ System is indicated for fixation of reconstruction and fusion of toes during correction procedures for hammertoe deformity, claw toe deformity, shortening osteotomies of the phalanges and mallet toe deformity as well as revision hammertoe procedures.
The cannulated and solid HammerTube™ implants may be used without any other additional device. The cannulated implants may be used with K-wires for delivery of implants or for the temporary stabilization of nearby joints, such as the metatarsophalangeal joint.
The implantable K-wires are indicated for use in the stabilization and fixation of small bones for use in bone reconstruction, osteotomy, arthrodesis, fracture repair and fixation, appropriate for the joint. Additionally, the implantable K-wires are indicated as guide pins for insertion of instruments and implants in the HammerTube™ System.
Type of Use (Select one or both, as applicable)
区 Prescription Use (Part 21 CFR 801 Subpart D)
] Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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| Date: | 8 June 2017 |
|---|---|
| Sponsor: | Paragon 28, Inc.4B Inverness Ct. E., STE 280Englewood, Colorado 80112Phone: (888) 728-1888Facsimile: (888) 728-1220 |
| Sponsor Contact: | Frank S. Bono, Chief Technology Officer |
| 510(k) Contact: | Karen E. Warden, PhDBackRoads ConsultingPO Box 566Chesterland, OH 44026Office: 440.729.8457 |
| Trade Names: | HammerTube™ System |
| Common Name: | Fixation pin |
| Regulatory Class: | Class II |
| Classification Name /Regulation / ProductCode: | Pin, Fixation, Smooth / 888.3040 / HTY |
| Device Description: | The HammerTube™ System includes HammerTube™ and K-wireimplants. the HammerTube™ is a commercially pure titanium plasmasprayed PEEK cylinder in varying diameters and lengths. The K-wires arestainless steel and double trocar pointed. |
| Indications for Use: | The HammerTube™ System is indicated for fixation of reconstruction andfusion of toes during correction procedures for hammertoe deformity,claw toe deformity, shortening osteotomies of the phalanges and mallettoe deformity as well as revision hammertoe procedures.The cannulated and solid HammerTube™ implants may be used withoutany other additional device. The cannulated implants may be used withK-wires for delivery of implants or for the temporary stabilization ofnearby joints, such as the metatarsophalangeal joint.The implantable K-wires are indicated for use in the stabilization andfixation of small bones for use in bone reconstruction, osteotomy,arthrodesis, fracture repair and fixation, appropriate for the size of thejoint. Additionally, the implantable K-wires are indicated as guide pins forinsertion of instruments and implants in the HammerTube™ System |
| Materials: | HammerTube™ System implants are manufactured frompolyetheretherketone (VESTAKEEP, Evonik per ASTM F2026) having acommercially pure titanium plasma spray coating as described by ASTMF1580 or from stainless steel per ASTM F138. |
| Primary Predicate: | aap Wire Bone (aap Implante AG – K131459) |
| Reference Device: | Tyber Medical Wedge System (Tyber Medical LLC – K150394) |
| Performance Data: | Static and dynamic cantilever bending, and static pullout testing wasperformed. |
| TechnologicalCharacteristics: | The HammerTube™ System K-wire implants possesses the sametechnological characteristics as the predicate device. These include:• performance,• basic design,• material and• sizes (dimensions are comparable to those offered by thepredicate systems).Differences between the HammerTube™ implants (material, design,sizes) were shown not to raise new questions of safety or effectiveness.Therefore the fundamental scientific technology of the HammerTube™System is similar to the predicate. |
| Conclusion: | The HammerTube™ System possesses indications for use andtechnological characteristics similar to the predicate device. Therefore theHammerTube™ System is substantially equivalent to the predicate. |
510(k) Summary
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§ 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.