(29 days)
The Alta® Fully Threaded Cross-Locking 5.0mm Screw is indicated for use in fractures requiring static and dynamic locking applications which include the Intramedullary Rods in the Alta® Femoral and Alta® Tibial /Humeral Rod Systems. Specifically, these screws will be used with the Alta® Femoral Locking IM Rod (K850441 & K822266), the Alta® CFX Reconstruction Rod (K926232, K935295, & K960524), the Alta® Tiblal/Humeral IM Rod (K884500, K890936, and K954554), and the Alta® Retrograde Rod (K972108).
The Alta® Fully Threaded Cross-Locking 5.0mm Screw is a cross-locking screw with continuous threading along the entire shaft. The design modification involves changing the hex head design to a T25 standard drive feature. The modified device will be a new screw for use with the Alta System. The modified component, the Alta® Fully Threaded Cross-Locking 5.0mm Screw, is substantially equivalent to the predicate device which was cleared for marketing via the 510(k) process. Alta® Fully Threaded 5.0mm Screws are manufactured from Titanium (Ti6Al-4V ELI) Alloy, which conforms to ASTM F-136.
The provided document is a 510(k) Premarket Notification for a medical device, the "Alta® Fully Threaded Cross-Locking 5.0mm Screw". This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with performance metrics.
Therefore, the document does not contain the information requested regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or human-in-the-loop study details.
Here's why and what information is available:
- Substantial Equivalence: The core of a 510(k) submission is to show that a new device is "substantially equivalent" to a predicate device already on the market. This typically involves comparing design features, materials, intended use, and performance claims (if any new claims are made) to the predicate. It does not usually involve new clinical studies or the establishment of new performance acceptance criteria for the device itself.
- Device Modification: This specific submission is a "Special 510(k)" for a design modification. The modification is changing the hex head design of an existing screw to a T25 standard drive feature. This further emphasizes that it's an update to a known device, not a brand-new one requiring extensive performance evaluations against new criteria.
- Focus on Claims: The document states, "The Alta® Fully Threaded Cross-Locking 5.0mm Screw is substantially equivalent to the predicate device which was cleared for marketing via the 510(k) process." This highlights that the review concerns equivalence, not new performance data.
Therefore, I cannot populate the table or answer the questions as the requested information is not present in this 510(k) summary.
However, I can provide the available relevant information from the document:
- Device Name: Alta® Fully Threaded Cross-Locking 5.0mm Screw
- Predicate Device: Osteo System Locking Screw (modified version)
- Design Modification: Changing the hex head design to a T25 standard drive feature.
- Material: Titanium (Ti6Al-4V ELI) Alloy, conforming to ASTM F-136.
- Intended Use: Identical to the Osteo System Locking Screw, for use in fractures requiring static and dynamic locking applications with specific Alta® Intramedullary Rod Systems.
- Regulatory Class: Class II
- Product Code: OR (87) HSB
To answer the detailed questions about acceptance criteria and performance studies, one would typically need access to the full 510(k) submission, including potentially bench testing data or prior predicate device testing documentation, which is not included in this summary.
{0}------------------------------------------------
ОСТ 6 1999
K99 3004
Alta® Fully Threaded Cross-Locking 5.0mm Screw
Special 510(k) Premarket Notification
Special 510(k) Summary - Device Modification Summary of Safetv and Effectiveness for the Alta® Fully Threaded Cross-Locking 5.0mm Screw
| Proprietary Name: | Alta® Fully Threaded Cross-Locking 5.0mmScrew |
|---|---|
| Common Name : | Intramedullary Fixation Rod |
| Classification Name and Reference : | Intramedullary Fixation Rod,21 CFR §888.3020 |
| Proposed Regulatory Class : | Class II |
| Device Product Code : | OR (87) HSB |
| For Information contact: | Jennifer A. Daudelin, Regulatory AffairsHowmedica Osteonics Corp.359 Veterans BoulevardRutherford, NJ 07070-2584(201) 507-7283Fax: (201) 507-6870 |
This Special 510(k) submission is intended to address a design modification to the predicate Osteo System Locking Screw. Osteo is a sister division of Stryker for whom Howmedica Osteonics is the sole US Distributor and the US Designated Agent responsible for filing 510(k)s. Throughout this document, the modified Osteo screw will be referred to as The Alta® Fully Threaded Cross-Locking 5.0mm Screw. The Alta® Fully Threaded Cross-Locking 5.0mm Screw is a cross-locking screw with continuous threading along the entire shaft. The design modification involves changing the hex head design to a T25 standard drive feature. The modified device will be a new screw for use with the Alta System. The modified component, the Alta® Fully Threaded Cross-Locking 5.0mm Screw, is substantially equivalent to the predicate device which was cleared for marketing via the 510(k) process. Alta® Fully Threaded 5.0mm Screws are manufactured from Titanium (Ti6Al-4V ELI) Alloy, which conforms to ASTM F-136. The intended use of the Alta® Fully Threaded Cross-Locking 5.0mm Screw is identical to that of the Osteo System Locking Screw.
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 6 1999
Ms. Jennifer A. Daudelin Regulatory Affairs Howmedica Osteonics Corporation 359 Veterans Boulevard Rutherford. New Jersey 07070-2584
Re: K993004
Trade Name: Alta Fully Threaded Cross-Locking 5.0 mm Screw Regulatory Class: II Product Code: JDS, HWC Dated: August 31, 1999 Received: September 07, 1999
Dear Ms. Daudelin:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
{2}------------------------------------------------
Page 2 - Ms. Jennifer Daudelin
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director
Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Althos Fully Threaded Cross-Locking 5.0mm Serew
Special 510(k) Promarket Notification
Indications for Use
510(k) Number (if known): K993004
Alta® Fully Threaded Cross Locking 5.0mm Screw Device Name:
Indications for Use:
The Alta® Fully Threaded Cross-Locking 5.0mm Screw is indicated for use in fractures requiring static and dynamic locking applications which include the Intramedullary Rods in the Alta® Femoral and Alta® Tibial /Humeral Rod Systems. Specifically, these screws will be used with the Alta® Femoral Locking IM Rod (K850441 & K822266), the Alta® CFX Reconstruction Rod (K926232, K935295, & K960524), the Alta® Tiblal/Humeral IM Rod (K884500, K890936, and K954554), and the Alta® Retrograde Rod (K972108).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use (Per 21 CFR 801.109) | X | OR | Over-The-Counter Use |
|---|---|---|---|
| --------------------------------------- | --- | ---- | ---------------------- |
(Optional Format 1-2-96)
(Division Sign-Off)
Division of General Restorative Devices
| 510(k) Number | K993004 |
|---|---|
| --------------- | --------- |
§ 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.