(67 days)
Not Found
No
The document describes a mechanical implant (femoral head) and focuses on material and manufacturing process improvements, with no mention of AI or ML.
Yes
The device is intended for total hip replacement to treat painful, disabling joint disease, correct functional deformity, and address fractures or nonunion, which are all therapeutic interventions.
No
This device is a surgical implant (femoral head) used in total hip replacement, not a diagnostic tool. Its purpose is to replace part of a joint, not to diagnose a condition.
No
The device description clearly states it is a physical femoral head, a component of a total hip replacement, manufactured from specific materials using manufacturing processes. It is 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 states it's for "total hip replacement" and is a "single-use device." This describes a surgical implant used directly in the body.
- Indications for Use: The indications are all related to conditions affecting the hip joint that require surgical intervention (arthritis, fractures, deformities, etc.).
- Device Description: The description focuses on the material, manufacturing process, and design of a physical implant (femoral head) that connects to a hip stem.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (blood, urine, tissue, etc.) or providing information for diagnosis, monitoring, or screening.
IVD devices are used to examine specimens from the human body to provide information for diagnostic purposes. This device is a surgical implant used to replace a part of the hip joint.
N/A
Intended Use / Indications for Use
The subject femoral head is a single-use device intended for use in total hip replacement. It is intended for use with any currently available Howmedica Osteonics acetabular component. It is intended for use with any currently available Howmedica Osteonics hip stem featuring the V40™ trunnion and manufactured from a titanium alloy or Orthinox™ Stainless Steel. It is not intended for use with any stem manufactured from cobalt chromium alloy.
Indications:
- Painful, disabling joint disease of the hip resulting from: Non-inflammatory degenerative . arthritis (osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, pelvic fracture, failed fracture fixation, or diastrophic variant);
- . Rheumatoid arthritis;
- Correction of functional deformity; .
- Where bone stock is of poor quality or inadequate for other reconstructive techniques as . indicated by deficiencies of the acetabulum;
- Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with . head involvement that are unmanageable uing other techniques;
- Revision procedures where other treatments or devices have failed. .
Product codes (comma separated list FDA assigned to the subject device)
87 LZO
Device Description
The subject Alumina V40™ Femoral Heads and the predicate Alumina V40™ Femoral Heads (#K003413) are manufactured from the same materials using the same manufacturing processes. They share the same indications for use and are of nearly identical design. The subject Alumina V40™ Femoral Heads differ from the predicate Alumina V40™ Femoral Heads as follows:
-
- An improved taper grinding technique provides a smoother taper surface finish. This smoother taper surface finish yields stronger ball heads that can now be used with Orthinox™ stainless steel stems (in addition to the titanium alloy stems previously cleared for use with the predicate femoral heads).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip
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.
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
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.
0
JAN 2 8 2003
Alumina V40™ Femoral Heads
023901
510(k) Premarket Notification
page 1 of 1
510(k) Summary
Alumina V40TM Femoral Heads
| Proprietary Name: | Alumina V40TM Femoral Heads |
|---|---|
| Common Name: | Artificial Hip Component |
| Classification Name and Reference: | Hip Joint, |
| Metal/Ceramic/Polymer, Semi-Constrained, | |
| Cemented or Nonporous Uncemented Prosthesis, | |
| 21 CFR §888.3353 | |
| Proposed Regulatory Class: | Class II |
| Device Product Code: | 87 LZO: Prosthesis, Hip, Semi-Constrained, Metal/ |
| Ceramic /Polymer, Cemented or Non-Porous, | |
| Uncemented | |
| Predicate Proprietary Name: | Alumina V40TM Femoral Heads |
| Predicate Regulatory Class: | Class II |
| Predicate Product Code: | 87 LZO |
| For Information contact: | Debra Bing |
| Howmedica Osteonics Corp. | |
| 59 Route 17 | |
| Allendale, New Jersey 07401-1677 | |
| Phone: (201) 831-5413 | |
| Fax: (201) 831-6038 |
Description/Technological Comparison
The subject Alumina V40™ Femoral Heads and the predicate Alumina V40™ Femoral Heads (#K003413) are manufactured from the same materials using the same manufacturing processes. They share the same indications for use and are of nearly identical design. The subject Alumina V40™ Femoral Heads differ from the predicate Alumina V40™ Femoral Heads as follows:
-
- An improved taper grinding technique provides a smoother taper surface finish. This smoother taper surface finish yields stronger ball heads that can now be used with Orthinox™ stainless steel stems (in addition to the titanium alloy stems previously cleared for use with the predicate femoral heads).
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing the bird's head and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 8 2003
Ms. Debra Bing Regulatory Affairs Manager Stryker Homedica Osteonics Corporation 59 Route 17 Allendale, New Jersey 07401-1677
Re: K023901
Trade Name: Alumina V40™ Femoral Heads Regulation Number: 21 CFR 888.3353 Regulation Name: Hip Joint, Metal/Ceramic/Polymer, Semi-Constrained, Cemented or Nonporous Uncemented Prosthesis Regulatory Class: II Product Code: LZO Dated: November 21, 2002 Received: November 22, 2002
Dear Ms. Bing:
We have reviewed your Section 510(k) premarket 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) 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 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.
2
Page 2 - Ms. Debra Bing
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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,
Sincerely yours,
Mark n Mllkerson
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
3
510(k) Number (if known): KO2390 /
Device Name: Alumina V40™ Femoral Heads
The subject femoral head is a single-use device intended for use in total hip replacement. It is intended for use with any currently available Howmedica Osteonics acetabular component. It is intended for use with any currently available Howmedica Osteonics hip stem featuring the V40™ trunnion and manufactured from a titanium alloy or Orthinox™ Stainless Steel. It is not intended for use with any stem manufactured from cobalt chromium alloy.
Indications:
- Painful, disabling joint disease of the hip resulting from: Non-inflammatory degenerative . arthritis (osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, pelvic fracture, failed fracture fixation, or diastrophic variant);
- . Rheumatoid arthritis;
- Correction of functional deformity; .
- Where bone stock is of poor quality or inadequate for other reconstructive techniques as . indicated by deficiencies of the acetabulum;
- Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with . head involvement that are unmanageable uing other techniques;
- Revision procedures where other treatments or devices have failed. .
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter Use (Per 21 CFR 801.109) (Optional Format 1-2-96)
Mark A. Milken
estorative .