(55 days)
Richards Retrograde Nail
Not Found
No
The device description focuses solely on the material and physical dimensions of a femoral nail and its accessories, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is indicated for long bone fracture fixation, specifically femoral fracture fixation, to treat various fracture types and nonunions, which are therapeutic actions.
No
The device description clearly states it is a femoral nail and its accessories used for "long bone fracture fixation," which is a treatment, not a diagnostic, procedure.
No
The device description explicitly details physical components made of titanium alloy, indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "long bone fracture fixation, specifically femoral fracture fixation." This describes a surgical implant used to stabilize bone fractures.
- Device Description: The description details the materials and dimensions of a femoral nail and its accessories (nut and washer), which are physical components implanted in the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The Osteo IC Retrograde/Antegrade Femoral Nail and its accessories are indicated for long bone fracture fixation, specifically femoral fracture fixation, which may include the following:
- . Open and closed femoral fractures
- Pseudoarthrosis and correction osteotomy
- Pathologic fractures, impending pathologic fractures, and tumor resections .
- Supracondylar fractures, including those with intra-articular extension
- Ipsilateral femur/tibia fractures
- . Fractures proximal to a total knee arthroplasty
- Fractures distal to a hip implant
- . Nonunions and malunions
Product codes (comma separated list FDA assigned to the subject device)
HSB
Device Description
The nut and washer for the Osteo IC Retrograde/Antegrade Femoral Nail are manufactured from ASTM F136-96 titanium alloy (Ti6Al-4V) and are anodized with a Type II coating process. The washer is 1.2mm thick, has a total diameter of 12mm, and a through-hole diameter of 5.2mm. The nut is T-shaped with an outer shaft diameter of 7mm, and inner shaft diameter of 5.5mm and a total length of 12mm. The head of the nut had a diameter of 12mm. The inner shaft of the nut is threaded in order to accommodate the threads of a locking screw. The washer is placed between the head of the locking screw and the bone surface. The nut is placed on the distal end of the screw. The 7mm diameter shaft of the nut sits below the surface of the bone, and the rounded 12mm diameter head of the nut will sit on the surface of the bone. All components of the Osteo IC Retrograde Femoral Nail are provided both sterile and non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral
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)
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.
Richards Retrograde Nail
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
§ 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
Summ
510(k) PREMARKET NOTIFICATION SUMMARY OF SAFETY AND EFFECTIVENESS Osteo IC Retrograde/Antegrade Femoral Nail - Accessories
| 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: | Kate Sutton (or Marybeth Naughton) |
| Regulatory Affairs Specialist | |
| Date Summary Prepared: | January 12, 1999 |
| Device Identification | |
| Proprietary Name: | Osteo IC Retrograde/Antegrade Femoral Nail |
| Common Name: | Intramedullary Nail, Femoral Nail |
| Classification Name and Reference: | Intramedullary Fixation Rod |
| 21 CFR §888.3020 |
Predicate Device Identification
The design and function of the Osteo IC Retrograde Femoral Nail nut and washer is substantially equivalent to the nut and washer of the predicate Richards Retrograde Nail. The subject and predicate systems offer femoral nails in varying lengths, and utilize a combination of locking screws, end caps, nuts, and washers.
Device Description
The nut and washer for the Osteo IC Retrograde/Antegrade Femoral Nail are manufactured from ASTM F136-96 titanium alloy (Ti6Al-4V) and are anodized with a Type II coating process. The washer is 1.2mm thick, has a total diameter of 12mm, and a through-hole diameter of 5.2mm. The nut is T-shaped with an outer shaft diameter of 7mm, and inner shaft diameter of 5.5mm and a total length of 12mm. The head of the nut had a diameter of 12mm. The inner shaft of the nut is threaded in order to accommodate the threads of a locking screw. The washer is placed between the head of the locking screw and the bone surface. The nut is placed on the distal end of the screw. The 7mm diameter shaft of the nut sits below the surface of the bone, and the rounded 12mm diameter head of the nut will sit on the surface of the bone. All components of the Osteo IC Retrograde Femoral Nail are provided both sterile and non-sterile.
1
Intended Use
The Osteo IC Retrograde/Antegrade Femoral Nail and its accessories are indicated for long bone fracture fixation, specifically femoral fracture fixation, which may include the following:
- . Open and closed femoral fractures
- Pseudoarthrosis and correction osteotomy
- Pathologic fractures, impending pathologic fractures, and tumor resections .
- Supracondylar fractures, including those with intra-articular extension
- Ipsilateral femur/tibia fractures
- . Fractures proximal to a total knee arthroplasty
- Fractures distal to a hip implant
- . Nonunions and malunions
Statement of Technological Comparison
The subject Osteo IC Retrograde Femoral Nail nut and washer are substantially equivalent in design and intended use to the predicate nut and washer offered by Richards.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three curved lines representing its body or wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 5 1090
Ms. Elizabeth A. Staub Director, Quality Assurance and Regulatory Affairs Howmedica Osteonics Corporation 59 Route 17 Allendale, New Jersey 07401-1677
K990152 Re: . Osteo IC Retrograde/Antegrade Femoral Nail - Accessories Requlatory Class: II Product Code: HSB Dated: January 12, 1999 Received: January 19, 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 controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 Requlations, 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 requlation may result in requlatory In addition, FDA may publish further announcements action. 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 requlations.
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.
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 99015 2
Device Name: Osteo IC Retrograde/Antegrade Femoral Nail - Accessories
Indications For Use:
The Osteo IC Retrograde/Antegrade Femoral Nail and its accessories are indicated for long bone fracture fixation, specifically femoral fracture fixation, which may include the following:
- . Open and closed femoral fractures.
- . Pseudarthrosis and correction osteotomy.
- . Pathologic fractures, impending pathologic fractures, and tumor resections.
- . Supracondylar fractures, including those with intra-articular extension.
- . Ipsilateral femur/tibia fractures.
- . Fractures proximal to a total knee arthroplasty.
- . Fractures distal to a hip implant.
- Nonunions and malunions. .
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Eva
vice Evaluation (ODE)
(Division Sign-Off) √
Division of General Restorative Devices
510(k) Number K990152
Prescription Use_ X
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)