(148 days)
The Herbert ™ Mini Bone Screw (2.5mm diameter, non- cannulated) and the Herbert ™ Bone Screw (3.0mm diameter, non-cannulated) are indicated for fixation of intra-articular and extra-articular fractures, avulsions, non- union, and osteotomies of small bones and small bone fragments; as well as arthrodeses of small joints.
The Herbert/Whipple ® Bone Screw System (3.0mm diameter, cannulated) are indicated for the fixation of fractures and non-unions of small bones and small bone arthrodeses, including, but not limited to, scaphoid fractures; intra-articular fractures of the tarsals, metatarsals, carpals and metacarpals; bunionectomies and osteotomies; arthrodeses of small joints (e.g. phalanges); fractures of the patella, ulna and radial styloid.
The Herbert ™ Cannulated Bone Screw System (4.5mm and 6.5mm diameter) are indicated for fracture fixation, reconstruction, osteotomy, and arthrodesis of various bones and bone fragments including joint fusions (arthrodeses) in the foot and fixation of intra-articular fractures of the humerus, femur and tibia.
The Herbert devices are cannulated and non-cannulated variable pitch screws that are headless, threaded at both ends and are made from Tivanium ® Ti-6Al-4V Alloy. Herbert screws are designed to provide rigid fixation for various fractures.
The supplied text does not describe an AI medical device, but rather a set of bone screws. Therefore, I cannot provide an answer to your request. The document discusses the Herbert/Whipple® Bone Screw System and related devices, focusing on their indications for use, design, and non-clinical performance data such as shelf life, biocompatibility, and mechanical performance. There is no mention of acceptance criteria or a study related to an AI device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 31, 2015
Zimmer, Incorporated Mr. Stephen H. McKelvey Senior Project Manager, Trauma Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581
Re: K143165
Trade/Device Name: Herbert/Whipple® Bone Screw System, Herbert™ Bone Screw. Herbert" Cannulated Bone Screw System, and Herbert" Mini Bone Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: February 27, 2014 Received: March 2, 2015
Dear Mr. McKelvey:
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
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Page 2 – Mr. Stephen H. McKelvey
(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 (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" (21CFR 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 yours,
Lori A. Wiggins -S
for 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
510(k) Number (if known)
K143165
Device Name
Herbert Whipple® Bone Screw System, Herbert™ Cannulated Bone Screw System, and Herber™ Mini Bone Screw
Indications for Use (Describe)
The Herbert™ Mini Bone Screw (2.5mm diameter, non-cannulated) and the Herbert™ Bone Screw (3.0mm diameter, non-cannulated) are indicated for fixation of intra-articular fractures, avulsions, non-union, and osteotomies of small bones and small bone fragments; as well as arthrodeses of small joints.
The Herbert/Whipple® Bone Screw System (3.0mm diameter, cannulated) are indicated for the fixation of fractures and non-unions of small bones and small bone arthrodeses, including, but not limited to, scaphoid fractures; intra-articular fractures of the tarsals, metatarsals, carpals; bunionectomies and osteotomies; arthrodeses of small joints (e.g. phalanges); fractures of the patella, ulna and radial styloid.
The Herbert™ Cannulated Bone Screw System (4.5mm diameter) are indicated for fracture fixation, reconstruction, osteotomy, and arthrodesis of various bone fragments including joint fusions (arthrodeses) in the foot and fixation of intra-articular fractures of the humerus, femur and tibia.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for Zimmer Biomet. The logo consists of a blue circle with a stylized letter "Z" inside. Below the circle, the word "zimmer" is written in lowercase blue letters.
| 510(k) Summary | |
|---|---|
| Sponsor: | Zimmer, Inc.P.O. Box 708Warsaw, IN 46581-0708 |
| Contact Person: | Stephen H. McKelvey, MA, RACSenior Project Manager, Regulatory AffairsTelephone: 574-372-4944Fax: (574) 372-4605 |
| Date: | October 30, 2014 |
| Trade Name: | Herbert/Whipple Bone Screw SystemHerbert Bone ScrewHerbert Cannulated Bone Screw SystemHerbert Mini Bone Screw |
| Common Name: | Screw, Fixation, Bone |
| Classification Namesand References: | Smooth or threaded metallic bone fixation fastener(21 CFR 888.3040, HWC) |
| Classification Panel: | Orthopedics/87 |
| Predicate Device(s): | Synthes 1.5mm Headless Compression Screws,manufactured by Synthes, K090949, cleared July 31,2009, Synthes 2.4mm Headless Compression Screws,manufactured by Synthes, K021556, cleared August 9,2002, Synthes 4.5mm and 6.5mm Headless CompressionScrews, manufactured by Synthes, K080943, cleared April23, 2008. |
| Purpose and DeviceDescription: | The Herbert devices are cannulated and non-cannulatedvariable pitch screws that are headless, threaded at bothends and are made from Tivanium ® Ti-6Al-4V Alloy.Herbert screws are designed to provide rigid fixation forvarious fractures. |
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| Intended Use: | The Herbert ™ Mini Bone Screw (2.5mm diameter, non- cannulated) and the Herbert ™ Bone Screw (3.0mm diameter, non-cannulated) are indicated for fixation of intra-articular and extra-articular fractures, avulsions, non- union, and osteotomies of small bones and small bone fragments; as well as arthrodeses of small joints. |
|---|---|
| The Herbert/Whipple ® Bone Screw System (3.0mm diameter, cannulated) are indicated for the fixation of fractures and non-unions of small bones and small bone arthrodeses, including, but not limited to, scaphoid fractures; intra-articular fractures of the tarsals, metatarsals, carpals and metacarpals; bunionectomies and osteotomies; arthrodeses of small joints (e.g. phalanges); fractures of the patella, ulna and radial styloid. | |
| The Herbert ™ Cannulated Bone Screw System (4.5mm and 6.5mm diameter) are indicated for fracture fixation, reconstruction, osteotomy, and arthrodesis of various bones and bone fragments including joint fusions (arthrodeses) in the foot and fixation of intra-articular fractures of the humerus, femur and tibia. | |
| Performance Data (Nonclinical and/or Clinical): | Non-Clinical Performance and Conclusions: |
| Shelf Life - Accelerated aging testing conducted shows that the sterile devices included in this submission have a shelf life of 10 years. | |
| Biocompatibility – Biocompatibility testing of the subject devices was conducted per ISO 10993-1 and Good Laboratory Practices (21 CFR 58). All testing passed. | |
| Performance Evaluation – The engineering analyses demonstrated the estimated axial pull out force, maximum torque to failure, and static bending moment of the Herbert devices met the predetermined requirements established for mechanical performance. | |
| Zimmer also conducted insertion torque and removal torque testing for each of the subject devices and compared the results to the maximum torque-to- failure. In all cases, the insertion and removal torques |
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were significantly less than the torque-to-failure for the screws, indicating that each of the subject screws can be inserted and removed during surgery without screw failure.
Conclusions: The data presented in this submission show that the changes do not affect the safety and/or effectiveness of the subject devices and that the subject devices will perform in a substantially equivalent manner to the predicate devices.
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for these devices to show substantial equivalence.
§ 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.