(90 days)
In cemented or cementless hip arthroplasty, when a screw hole plug is thought to be advantageous
The Trident® Screw Hole Plugs are small, threaded circular plugs which are intended to occlude acetabular screw holes not occupied by bone screws or the Trident® Bone Spike (subject device). The Trident® Screw Hole Plugs are fabricated from commercially pure titanium (CP Titanium). The Trident® Screw Hole Plugs incorporate a recess to accept a TORX® head screwdriver to allow the surgeon to place the desired number of plugs into the Trident® shell intraoperatively. The Trident® Screw Hole Plugs are intended to be inserted from the inside of the Trident® shell.
The Trident® Screw Hole Plugs, by occluding the shell screw holes, will help prevent intrusion of bone cement into the shell (when used in the cemented mode) or fibrous tissue (when used in a cementless mode), and potential migration of debris through open screw holes into the acetabulum.
The Trident® Bone Spike is fabricated from titanium alloy (Titanium 6 Aluminum 4 Vanadium), and is available in two lengths: 7mm and 9mm. The Trident® Bone Spike has a threaded base that is assembled to the screw hole(s) of the appropriate Trident® shell at the time of surgery. The undersurface of the base incorporates a recess to accept a TORX® screwdriver. The superior portion of the device is a spike that is intended to provide purchase into the prepared bone of the acetabulum. The surgeon has the option of using the Trident® Bone Spike in place of the Osteonics® Cancellous Bone Screws to provide supplemental fixation of the Trident® shell.
The provided text is a 510(k) Premarket Notification for the Trident® Screw Hole Plug and Trident® Bone Spike. This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than providing extensive de novo clinical study data to define and prove acceptance criteria for novel performance claims.
Therefore, the document does not contain the detailed information typically found in a clinical study report that would establish specific acceptance criteria and then demonstrate a device's performance against those criteria in a comprehensive manner. Instead, the submission relies on the concept of substantial equivalence, meaning the new device is as safe and effective as a previously cleared device.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance: This information is not explicitly stated or quantified in terms of clinical outcomes or performance metrics.
- Sample size, data provenance for a test set, number of experts, adjudication method, MRMC study, standalone performance, or type of ground truth for a test set: These are all elements of a clinical effectiveness study, which is not presented here. The submission refers to "Testing was presented to support a claim of substantial equivalence," but the details of this testing are not provided in the excerpts. This "testing" likely refers to bench testing (e.g., mechanical strength, material compatibility) rather than clinical performance studies.
- Sample size or ground truth establishment for a training set: Since no machine learning or AI component is mentioned, there would be no "training set."
What the document does provide is:
- Device Identification: Proprietary names, common names, classification, and product codes.
- Intended Use/Indications: Clearly describes the purpose and conditions under which the devices are to be used (e.g., occluding screw holes, supplemental fixation in hip arthroplasty).
- Contraindications: Specific conditions where the devices should not be used (e.g., obesity).
- Material and Design: Details about the materials (CP Titanium, Titanium 6 Aluminum 4 Vanadium) and design features (threaded plugs, TORX® recess, spike).
- Substantial Equivalence Claim: The core of the 510(k) submission, stating that the device is substantially equivalent to predicate devices. The FDA's letter (K022799) confirms this determination.
In summary, based only on the provided text, it is not possible to describe the acceptance criteria and study that proves the device meets them in the requested format. The document's purpose is to demonstrate substantial equivalence, not to present a de novo clinical study with quantifiable acceptance criteria for clinical performance.
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Trident® Screw Hole Plug and Trident® Bone Spike 510(k) Premarket Notification Confidential 02079 510(k) Summary Submission Information Howmedica Osteonics Corp. Name and Address of Sponsor: NOV 2 1 2002 59 Route 17 Allendale, NJ 07401 For Information contact: Margaret F. Crowe Regulatory Affairs Consultant Howmedica Osteonics Corp. 59 Route 17 Allendale, NJ 07401 Device Identification Trident® Screw Hole Plug and Trident® Bone Proprietary Name: Spike Acetabular Screw Hole Plug Common Name: Smooth Metallic Bone Fixation Fastener Classification Name and Reference: Trident® Screw Hole Plug: 21 CFR &88.3350 Prosthesis, Hip, Semi-constrained Cemented or 21 CFR &88.3358 Hip Joint Metal/Polymer/Metal Semi-constrained Porous Coated Uncemented Prosthesis Trident® Bone Spike 21 CFR 8888.3040 Smooth or Threaded Metallic Bone Fixation Fastener Class II Proposed Regulatory Class: Trident® Screw Hole Plug: OR (87) JD I Device Product Code: OR (87) LPH Trident® Bone Spike: OR (87) HWC
The Trident® Screw Hole Plugs are optional single-use devices that are intended to occlude the unused screw holes of the Trident® Porous Titanium Acetabular Component
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or the Trident® Porous Titanium Acetabular Component with Peri-Apatite™ Coating The Trident® Screw Hole Plugs will be used either with or without bone cement depending upon the appropriate surgical application of the Trident® shell.
The Trident® Screw Hole Plugs are intended to be used in situations where the Trident® Porous Titanium Acetabular Components are intended to be used. More specifically, these Trident® Screw Holes Plugs have the following indications and contraindications:
Indications
- In cemented or cementless hip arthroplasty, when a screw hole plug is thought to be . advantageous
Contraindications
- Obesity. An overweight or obese patient can produce loads on the prosthesis which . can lead to failure of the fixation of the device or to failure of the device itself.
The Trident® Bone Spikes are optional single-use devices that are intended to provide supplemental fixation of the Trident® Porous Titanium Acetabular Shell or the Trident® Porous Titanium Acetabular Shell with Peri-Apatite™ Coating in the prepared acetabulum in total hip arthroplasty. These Trident® Bone Spikes are intended to be used when the above-referenced Trident® acetabular shells are used in a press fit application.
More specifically, these Trident® Bone Spikes have the following indications and contraindications:
- Trident® Bone Spikes are intended for supplemental fixation of the Trident® Porous . Titanium Acetabular Shell and the Trident® Porous Titanium Acetabular Shell with Peri-Apatite Coating only.
- Trident® Bone Spikes should be assembled to the Trident® acetabular shell prior to . placement of the shell into the prepared acetabulum.
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Trident® Screw Hole Plug and Trident® Bone Spike Confidential
022799
510(k) Premarket Notification
page 3 of 3
The Trident® Screw Hole Plugs are small, threaded circular plugs which are inten occlude acetabular screw holes not occupied by bone screws or the Trident® Bone Spike (subject device). The Trident® Screw Hole Plugs are fabricated from commercially pure titanium (CP Titanium). The Trident® Screw Hole Plugs incorporate a recess to accept a TORX® head screwdriver to allow the surgeon to place the desired number of plugs into the Trident® shell intraoperatively. The Trident® Screw Hole Plugs are intended to be inserted from the inside of the Trident® shell.
The Trident® Screw Hole Plugs, by occluding the shell screw holes, will help prevent intrusion of bone cement into the shell (when used in the cemented mode) or fibrous tissue (when used in a cementless mode), and potential migration of debris through open screw holes into the acetabulum.
The Trident® Bone Spike is fabricated from titanium alloy (Titanium 6 Aluminum 4 Vanadium), and is available in two lengths: 7mm and 9mm. The Trident® Bone Spike has a threaded base that is assembled to the screw hole(s) of the appropriate Trident® shell at the time of surgery. The undersurface of the base incorporates a recess to accept a TORX® screwdriver. The superior portion of the device is a spike that is intended to provide purchase into the prepared bone of the acetabulum. The surgeon has the option of using the Trident® Bone Spike in place of the Osteonics® Cancellous Bone Screws to provide supplemental fixation of the Trident® shell.
Testing was presented to support a claim of substantial equivalence.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 .
NOV 21 2002
Ms. Margaret F. Crowe Regulatory Affairs Consultant Howmedica Osteonics Corp. 59 Route 17 Allendale, New Jersey 07401
Re: K022799
Trade/Device Name: Trident® Screw Hole Plug and Trident® Bone Spike Regulation Numbers: 21 CFR 888.3350, 21 CFR 888.3358, and 21 CFR 888.3040 Regulation Names: Hip joint metal/polymer semi-constrained cemented prosthesis; Hip ioint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis; and Smooth or threaded metallic bone fixation fastener Regulatory Class: II
Product Code: JDI, LPH, HWC Dated: August 22, 2002 Received: August 23, 2002
Dear Ms. Crowe:
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
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Page 2 - Ms. Margaret F. Crowe
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality 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 (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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Miriam C. Provost
For Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): KCQನ799
Trident® Screw Hole Plug and Trident® Bone Spike Device Name:
The Trident® Screw Hole Plugs are optional single-use devices that are intended to occlude the unused screw holes of the Trident® Porous Titanium Acetabular Component or the Trident® Porous Titanium Acetabular Component with Peri-Apatite™ Coating. The Trident® Screw Hole Plugs will be used either with or without bone cement depending upon the surgical application of the Trident® shell.
More specifically, these Trident® Screw Holes Plugs have the following indications and contraindications:
Indications
- In cemented or cementless hip arthroplasty, when a screw hole plug is thought to be . advantageous
Contraindications
- Obesity. An overweight or obese patient can produce loads on the prosthesis which . can lead to failure of the fixation of the device or to failure of the device itself.
The Trident® Bone Spikes are optional single-use devices that are intended to provide supplemental fixation of the Trident® Porous Titanium Acetabular Shell or the Trident® Porous Titanium Acetabular Shell with Peri-Apatite™ Coating in the prepared acetabulum in total hip arthroplasty. These Trident® Bone Spikes are intended to be used when the above-referenced Trident® acetabular shells are used in a press fit application.
More specifically, these Trident® Bone Spikes have the following indications and contraindications:
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Trident® Screw Hole Plug and Trident® Bone Spike _____________________________________________________________________________________________________________________________ !・・・
- Trident® Bone Spikes are intended for supplemental fixation of the Trident® Porous ● . Titanium Acetabular Shell and the Trident® Porous Titanium Acetabular Shell with Peri-Apatite Coating only.
- Trident® Bone Spikes should be assembled to the Trident® acetabular shell prior to placement of the shell into the prepared acetabulum.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ____________________ OR 801.109)
Over-the Counter-Use_______ (per 21 CFR
iriam C. Provost
(Division Sign-Off) (Division of General, Restorative and Neurological Devices
510(k) Number K022799
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.