(37 days)
Apex® Pins are intended for use in conjunction with external fixators in children and adults. Specific indications include, but not limited to the following conditions: bone fracture fixation for open, closed and/or unstable fractures, osteotomies, arthrodeses, deformity correction including bone transport, revision procedures where other treatments or devices have been unsuccessful or bone reconstruction procedures. The pins will be available with and without hydroxylapatite (HA) coating.
This submission is a line extension to the Apex® Pin product line to include fixation pins coated with hydroxylapatite (HA) to improve purchase in osteoporotic bone and for use in long-term fixation to reduce the incidence of pin loosening by enhancing the fixation at the pin-bone interface. The Apex® Pins are external fixation pins used with external fixators for fracture fixation. They are intended to be used with the other components in Howmedica Osteonics' external fixation systems.
The provided text is a 510(k) Summary for the Apex® Pins with HA Coating. This summary describes a medical device and its intended use, but it does not contain the results of a study designed to demonstrate device performance against specific acceptance criteria in the way a clinical or in-vitro diagnostic study would.
Instead, this document focuses on demonstrating Substantial Equivalence to a predicate device based on design, materials, intended use, and operational principles. For a Class II device like this, the primary "study" referred to is mechanical testing and characterization of the HA coating to show equivalence in strength.
Therefore, many of the requested fields cannot be filled as they pertain to clinical performance studies, which are not detailed in this 510(k) summary. I will fill in the applicable information and note when the requested information is not available in the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Strength | The Apex® Pins with HA coating must be substantially equivalent in strength to the predicate (uncoated Apex® Pins) and other commercially available uncoated and HA coated pins. (Implied: The HA coating should not compromise the pin's mechanical integrity). | "Testing was conducted to compare the subject HA coated pins to its uncoated predicate for mechanical strength... The results demonstrate that the subject pins are substantially equivalent in strength to the predicate pins with and without HA coating." (Specific values not provided in this summary). |
| HA Coating Characterization | The HA coating must be characterized to ensure its properties are consistent with its intended function (to improve purchase in osteoporotic bone and reduce pin loosening). | "Testing was conducted... to characterize the HA coating." (Specific characterization results or pre-defined acceptance metrics for the coating itself are not detailed in this summary). |
| Substantial Equivalence | The device must demonstrate substantial equivalence to legally marketed predicate devices in terms of intended use, design, materials, and operational principles. | The FDA concluded, "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the provided summary. The summary only mentions "Testing was conducted."
- Data Provenance: Not specified. It can be inferred that the mechanical testing was likely conducted in a lab setting by the manufacturer (Howmedica Osteonics Corp.).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not applicable and not provided. The study mentioned (mechanical testing) does not involve expert review or "ground truth" in the clinical sense.
4. Adjudication method for the test set
- This information is not applicable and not provided. The study mentioned (mechanical testing) does not involve adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, a multi-reader multi-case comparative effectiveness study was not done. This device is a physical medical implant (an external fixation pin), not an AI-assisted diagnostic or imaging device used by human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This information is not applicable. This device is a physical medical implant, not an algorithm.
7. The type of ground truth used
- The concept of "ground truth" as typically used in diagnostic or AI studies (e.g., pathology, expert consensus, outcomes data) does not directly apply here. Instead, the "truth" for this device's performance relies on:
- Mechanical Test Standards and Measurements: Objective measurements of mechanical properties (e.g., strength, stiffness, fatigue resistance) according to recognized engineering standards.
- Material Characterization Techniques: Analytical methods to confirm the composition and properties of the HA coating.
- Comparison to Predicate: Performance is assessed against a legally marketed predicate device to demonstrate substantial equivalence, rather than an absolute clinical "ground truth."
8. The sample size for the training set
- This information is not applicable. Mechanical testing and material characterization studies do not typically involve a "training set" in the context of machine learning or statistical modeling.
9. How the ground truth for the training set was established
- This information is not applicable. (See #8).
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JUL - 7 2006
510(k) Summary of Safety and Effectiveness Apex® Pins with HA Coating
| Proprietary Name: | Apex® Pins |
|---|---|
| Common Name: | External Fixation Pins |
| Classification Name/Reference: | Smooth or threaded metallic bone fixationfastener - 21 CFR §888.3040 |
| Device Product Code: | 87 JDW |
| Proposed Regulatory Class: | Class II |
| For Information contact: | Vivian Kelly, Regulatory Affairs SpecialistHowmedica Osteonics Corp.325 Corporate DriveMahwah, NJ 07430Phone: (201) 831-5581 Fax: (201) 831-6038 |
| Date Summary Prepared: | May 30, 2006 |
Description
This submission is a line extension to the Apex® Pin product line to include fixation pins coated with hydroxylapatite (HA) to improve purchase in osteoporotic bone and for use in long-term fixation to reduce the incidence of pin loosening by enhancing the fixation at the pin-bone interface. The Apex® Pins are external fixation pins used with external fixators for fracture fixation. They are intended to be used with the other components in Howmedica Osteonics' external fixation systems.
Indications:
Apex® Pins are intended for use in conjunction with external fixators in children and adults. Specific indications include, but not limited to the following conditions: bone fracture fixation for open, closed and/or unstable fractures, osteotomies, arthrodeses, deformity correction including bone transport, revision procedures where other treatments or devices have been unsuccessful or bone reconstruction procedures. The pins will be available with and without hydroxylapatite (HA) coating.
Substantial Equivalence:
Apex® Pins with hydroxylapatite (HA) coating are substantially equivalent to other commercially available uncoated and HA coated pins in regards to intended use, design, materials, and operational principles as external fixation pins. Testing was conducted to compare the subject HA coated pins to its uncoated predicate for mechanical strength and to characterize the HA coating. The results demonstrate that the subject pins are substantially equivalent in strength to the predicate pins with and without HA coating.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 7 2006
Stryker Howmedica Osteonics Corp. % Ms. Vivian Kelly Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430
Re: K061493
Trade/Device Name: Apex® Pins Regulation Number: 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: JDW Dated: May 30, 2006 Received: May 31, 2006
Dear Ms. Vivian Kelly:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality
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Page 2 - Ms. Vivian Kelly
systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120 . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Barbara Prieur
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
KO61493 510(k) Number (if known):
Device Name: Apex® Pins
Indications for Use:
Apex® Pins are intended for use in conjunction with external fixators in children and adults. Specific indications include, but not limited to the following conditions: bone fracture fixation for open, closed and/or unstable fractures, osteotomies, arthrodeses, deformity correction including bone transport, revision procedures where other treatments or devices have been unsuccessful or bone reconstruction procedures. The pins will be available with and without hydroxylapatite (HA) coating.
Prescription Use Over-The-Counter Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Barbara Buckley
Division of General, Restorative, and Neurological Devices
510(k) Number K061493
§ 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.