(77 days)
Osteo IC Femoral and Tibial Nails in Stainless Steel
Howmedica Alta Femoral and Tibial Rod System in Titanium Alloy
No
The summary describes a mechanical implant (femoral and tibial nails) and focuses on material and minor design changes compared to a predicate device. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes.
The device is used to treat fractures, pseudarthrosis, and other bone conditions, which are therapeutic interventions.
No
The device is described as an orthopedic implant (nails) used for treating fractures and other bone conditions, not for diagnosing them. Its purpose is to fix bones, not to provide diagnostic information.
No
The device description clearly states it is a physical medical device (femoral and tibial nails) made of titanium alloy, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for the treatment of bone fractures and related conditions in the femoral and tibial bones. This is a therapeutic use, not a diagnostic one.
- Device Description: The description details a physical implant (nails) made of titanium alloy, designed to be inserted into bones. This is consistent with a surgical implant, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
Therefore, this device falls under the category of a surgical implant or orthopedic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The indications for the use of the Osteo IC Femoral and Tibial Nails in Titanium Alloy are as follows:
- . Closed and open femoral and tibial shaft fractures
- Pseudarthrosis and correction osteotomies in the shaft area ●
- Pathological fractures and tumor resections of the shaft area .
- . Change of procedure following external fixation.
Product codes (comma separated list FDA assigned to the subject device)
HSB
Device Description
The subject Osteo IC Femoral and Tibial Nails are similar to the predicate Osteo IC Femoral and Tibial Nails. The major difference is that the subject devices are made from Titanium Alloy, while the predicate devices were made from Stainless Steel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral and tibial bones
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
The subject devices are so similar to the predicate devices cited in terms of design, materials, intended use, and size range, that additional testing was not thought necessary to demonstrate their Substantial Equivalence.
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.
Osteo IC Femoral and Tibial Nails in Stainless Steel
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.
Howmedica Alta Femoral and Tibial Rod System in Titanium Alloy
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
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the date "SEP 3 1999". The month is abbreviated to "SEP". The day is "3" and the year is "1999". The text is in bold font.
K992063
1 OF 2
510(k) SUMMARY Osteo IC Femoral and Tibial Nails in Titanium Alloy
| Submission Information | |
|---|---|
| Name and Address of the Sponsor of the 510(k) Submission: | Howmedica Osteonics Corp. 59 Route 17 Allendale, NJ 07401-1677 201-825-4900 |
| Contact Person: | Marybeth Naughton Regulatory Affairs Specialist |
| Date Summary Prepared: | June 15, 1999 |
| Device Identification | |
| Proprietary Name: | Osteo IC Femoral and Tibial Nails in Titanium Alloy |
| Common Name: | Intramedullary Nail, Tibial Nail |
| Classification Name and Reference: | Intramedullary Fixation Rod 21 CFR §888.3020 |
Predicate Device Identification
The subject Osteo IC Femoral and Tibial Nails in Titanium Alloy are compared to the following predicate devices:
- . Osteo IC Femoral and Tibial Nails in Stainless Steel
- . Howmedica Alta Femoral and Tibial Rod System in Titanium Alloy
Device Description
The subject Osteo IC Femoral and Tibial Nails are similar to the predicate Osteo IC Femoral and Tibial Nails. The major difference is that the subject devices are made from Titanium Alloy, while the predicate devices were made from Stainless Steel.
Intended Use
The intended uses of the subject Osteo IC Femoral and Tibial Nails are the same as those of the predicate Osteo IC Femoral and Tibial Nails. The nails are single use devices. They are intended for the fixation, correction, or stabilization of tibial and femoral bones. The nails may be locked statically, dynamically, or with active primary compression. The indications for use of the subject
1
K 992063
20Fd
510(k) Summary Osteo IC Femoral and Tibial Nails in Titanium Alloy
Osteo IC Femoral and Tibial Nails are the same as those of the predicate Osteo IC Femoral and Tibial Nails:
- . Closed and open femoral and tibial shaft fractures
- . Pseudarthrosis and correction osteotomies in the shaft area
- . Pathological fractures and tumor resections of the shaft area
- . Change of procedure following external fixation
Statement of Technological Comparison
The subject Osteo IC Femoral and Tibial Nails in Titanium share the same basic design as the Osteo IC Femoral and Tibial Nails in Stainless Steel, except that they feature an additional groove and come in some additional sizes. The predicate Howmedica Alta Nails, presented as one of the comparison devices for substantial equivalence, are manufactured from Titanium and come in a wider range of sizes than presented for the subject devices.
Performance Data:
The subject devices are so similar to the predicate devices cited in terms of design, materials, intended use, and size range, that additional testing was not thought necessary to demonstrate their Substantial Equivalence.
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three stylized human profiles facing to the right.
3 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Elizabeth A. Staub Director, Quality Assurance & Regulatory Affairs Stryker® Howmedica Osteonics 59 Route 17 Allendale. New Jersey 07401-1677
Re: K992063
Trade Name: Osteo IC Femoral and Tibial Nails in Titanium Alloy Regulatory Class: II Product Code: HSB Dated: June 15, 1999 Received: June 18, 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,
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_______
Device Name: Osteo IC Femoral and Tibial Nails in Titanium Alloy
Indications For Use:
The indications for the use of the Osteo IC Femoral and Tibial Nails in Titanium Alloy are as follows:
- . Closed and open femoral and tibial shaft fractures
- Pseudarthrosis and correction osteotomies in the shaft area ●
- Pathological fractures and tumor resections of the shaft area .
- . Change of procedure following external fixation.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K992063 |
| Prescription Use | X |
| (Per 21 CFR 801.109) | |
| OR | |
| Over-The-Counter Use | |
| (Optional Format 1-2-96) |