(21 days)
Not Found
No
The device description and intended use are purely mechanical and material-based, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" field is explicitly "Not Found".
No
The device is described as an accessory product (distal hole plug) used in cemented hip arthroplasty, and its function is to secure in the distal end of a hip stem, rather than directly treating or diagnosing a medical condition.
No
The device is a plug used in cemented hip arthroplasty for mechanical purposes (to act as a cement spacer or restrictor), not for diagnosing a condition or disease.
No
The device description clearly states the device is a single-use component manufactured from polymethylmethacrylate (PMMA) or PMMA mixed with Barium Sulfate (BaSO2), indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue taken from the human body to detect diseases, conditions, or infections.
- Device Function: The Osteonics® Universal Distal Hole Plug is a physical component used during a surgical procedure (cemented hip arthroplasty) and is implanted into the patient's body. It does not analyze biological samples.
- Intended Use: The intended use describes its role as a "cement spacer, mid-shaft restrictor, distal plug, and cement plug" within the context of hip replacement surgery. This is a mechanical function, not a diagnostic one.
Therefore, the device's purpose and mechanism of action clearly fall outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
The indications for the use of the Osteonics® Universal Distal Hole Plug, in keeping with those of other legally marketed Osteonics accessory products for cemented arthroplasty, are as follows:
For cement spacers, mid-shaft restrictors, distal plugs, and cement plugs:
- In cemented hip arthroplasty, when the cement spacer, restrictor and/or plug is thought to be advantageous.
Product codes (comma separated list FDA assigned to the subject device)
LZN
Device Description
The Osteonics® Universal Distal Hole Plug is a single use component which is intended for optional use in cemented arthroplasties of the hip as determined by the physician. The Universal Distal Hole Plugs are manufactured from polymethylmethacrylate (PMMA) or PMMA mixed with Barium Sulfate (BaSO2) and are available in one universal size. The Universal Distal Hole Plug is cylindrical in shape, has a rounded distal tip, and flares very slightly from the proximal to the distal end. The Universal Distal Hole Plug also employs a friction-fit design which secures it in the distal hole of any commercially available Osteonics® cemented hip stem. The Universal Distal Hole Plug is assembled to the hip stem intraoperatively and inserted into the femoral canal.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hip / femoral canal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician / cemented hip arthroplasty (surgical setting)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.
0
AUG 13 1999
510(k) Premarket Notification Summary of Safety and Effectiveness for the Osteonics® Universal Distal Hole Plug
Submission Information
| Name and Address of the Sponsor
of the 510(k) Submission: | Howmedica Osteonics Corp.
59 Route 17
Allendale, NJ 07401-1677 |
|--------------------------------------------------------------|----------------------------------------------------------------------|
| Contact Person: | Kate Sutton or Marybeth Naughton
Regulatory Affairs Team |
| Date of Summary Preparation: | July 12, 1999 |
| Device Identification | |
| Proprietary Name: | Osteonics® Universal Distal
Hole Plug |
| Common Name: | Cement Plug |
Classification Name and Reference:
Surgical Mesh 21 CFR §878.3300
Predicate Device Identification
The Osteonics® Distal Hole Plug employ features which are substantially equivalent to features of the following Howmedica Osteonics predicate devices, which has been cleared for marketing via the 510(k) process:
- Osteonics® Omnifit® Universal Distal Cement Spacer (K914406) .
- Osteonics® Universal Distal Spacer (K894708)
Device Description
The Osteonics® Universal Distal Hole Plug is a single use component which is intended for optional use in cemented arthroplasties of the hip as determined by the physician. The Universal Distal Hole Plugs are manufactured from polymethylmethacrylate (PMMA) or PMMA mixed with Barium Sulfate (BaSO2) and are available in one universal size. The Universal Distal Hole
1
Plug is cylindrical in shape, has a rounded distal tip, and flares very slightly from the proximal to The Universal Distal Hole Plug also employs a friction-fit design which secures it in distal end. the distal hole of any commercially available Osteonics® cemented hip stem. The Universal Distal Hole Plug is assembled to the hip stem intraoperatively and inserted into the femoral canal.
Intended Use:
The indications for the use of the Osteonics® Universal Distal Hole Plug, in keeping with those of other legally marketed Howmedica Osteonics accessory products for cemented arthroplasty, are as follows:
For cement spacers, mid-shaft restrictors, and Cement-Plugs:
- In cemented hip arthroplasty, when the cement spacer, restrictor and/or plug is thought to be advantageous.
Statement of Technological Comparison:
The Osteonics® Universal Distal Hole Plug is substantially equivalent, in terms of material and basic mechanical function, to the legally marketed versions of the predicate Osteonics® Omnifit® Universal Distal Cement Spacer, manufactured from PMMA mixed with Barium Sulfate, and the predicate Osteonics® Universal Distal Spacer, manufactured from PMMA. The subject and predicate devices are all intended to address similar conditions. However, the predicate devices have fins used for centering the spacer in the femoral canal, whereas the subject device has no fins and serves only to occlude the distal hole of the cemented hip stem in order to prevent cement from intruding into the distal hole. The Universal Distal Hole Plug is available in one universal size because, unlike the predicate device, the subject device does not incorporate fins. Each of the subject and predicate devices is for optional use and is provided in order to accommodate physician preference.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human profiles beneath a horizontal bar, representing care and protection.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 3 1999
Ms. Elizabeth A. Staub Vice President Quality Assurance Howmedica Osteonics Corporation 59 Route 17 Allendale. New Jersey 07401-1677
K992462 Re:
Trade Name: Osteonics Universal Distal Cement Plug Regulatory Class: II Product Code: LZN Dated: July 21, 1999 Received: July 23, 1999
Dear Ms. Staub:
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 control provisions of the Act. The general control 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.
3
Page 2 - Ms. Elizabeth A. Staub
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 (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
4
510(k) Number (if known): K 99 a 46 2
Device Name: Osteonics® Universal Distal Hole Plug
Indications For Use:
The indications for the use of the Osteonics® Universal Distal Hole Plug, in keeping with those of other legally marketed Osteonics accessory products for cemented arthroplasty, are as follows:
For cement spacers, mid-shaft restrictors, distal plugs, and cement plugs:
- In cemented hip arthroplasty, when the cement spacer, restrictor and/or plug is thought to be advantageous.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
(Division Sign-Off)
Division of General Restorative Devices K992462