(86 days)
Not Found
No
The document describes a hip implant component and does not mention any AI or ML technology.
Yes
The device is intended for total hip replacement to treat various joint diseases and correct functional deformities. These are therapeutic interventions aimed at restoring function and alleviating symptoms.
No
The device is a component of a total hip replacement system, addressing conditions like arthritis and fractures, and does not diagnose or identify medical conditions.
No
The device description clearly states it is a hip system component fabricated from a stainless steel alloy, indicating it is a physical medical device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for total hip replacement, which is a surgical procedure involving the implantation of a medical device into the body. IVDs are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health.
- Device Description: The device is a femoral head component made of stainless steel alloy, designed to be part of a hip implant. This is a physical implantable device, not a diagnostic test kit or instrument used for analyzing biological samples.
- Anatomical Site: The anatomical site is the hip joint, which is where the device is implanted. IVDs do not have an anatomical site in this context; they are used to analyze samples taken from the body.
The description clearly points to this being a surgical implant used for treatment, not a diagnostic tool used for testing biological samples.
N/A
Intended Use / Indications for Use
The subject Exeter V40™ Hip System components are intended for use in total hip replacement. They are intended for cemented use only. The subject components are intended for use with any Howmedica Osteonics Corp. acetabular component featuring a polyethylene bearing surface.
Indications:
- Noninflammatory joint disease including osteoarthritis and avascular necrosis,
- . Rheumatoid arthritis,
- Correction of functional deformity,
- Revision procedures where other treatments or devices have failed, .
- . Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Product codes (comma separated list FDA assigned to the subject device)
JDI
Device Description
This Special 510(k) submission is intended to add 36mm Orthinox® V40™ femoral head components in -5mm, +0mm, and +5mm offsets to the Exeter Femoral Bearing Series. The intended use, manufacturing methods, materials, packaging and sterilization of the subject device are identical to those of predicate devices. The predicate Orthinox® V40™ femoral bearing components were found substantially equivalent via the 510(k) process in K011623. The Orthinox® V40™ femoral head components are fabricated from Orthinox®, a Stainless Steel Alloy conforming to ASTM F1586 and ISO 5832-9. Like the predicate devices, the subject devices are intended for use with femoral stems and acetabular components in primary or revision total hip arthroplasty.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip Joint, Proximal Femur
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
§ 888.3350 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.
0
AUG 2 9 2003
Special 510(k) Summary - Addition of 36mm Orthinox® V40™ Femoral Heads To The Exeter Series
| SUBJECT DEVICE | PREDICATE DEVICE | |
|---|---|---|
| Proprietary Name: | 36mm Orthinox® V40™ Femoral | |
| Head Components | 22mm-32mm V40™ Orthinox® | |
| Femoral Head Components | ||
| Common Name: | Femoral Head Component | Femoral Head Component |
| Classification Name and | ||
| Reference: | 21 CFR §888.3350 | |
| Hip Joint Metal/ Polymer Semi- | ||
| constrained Cemented Prosthesis | 21 CFR §888.3350 | |
| Hip Joint Metal/ Polymer Semi- | ||
| constrained Cemented Prosthesis | ||
| Proposed Regulatory Class: | II | II |
| Device Product Code: | (87) JDI | (87) JDI |
| For Information contact: | Jennifer A. Daudelin, Regulatory Affairs | |
| Howmedica Osteonics Corp. | ||
| 59 Route 17 | ||
| Allendale, NJ 07401-1677 | ||
| (201) 831-5379 | ||
| Fax: (201) 831-6038 | ||
| Email: jdaudelin@howost.com | ||
| Date Summary Prepared: | May 27, 2003 |
This Special 510(k) submission is intended to add 36mm Orthinox® V40™ femoral head components in -5mm, +0mm, and +5mm offsets to the Exeter Femoral Bearing Series. The intended use, manufacturing methods, materials, packaging and sterilization of the subject device are identical to those of predicate devices. The predicate Orthinox® V40™ femoral bearing components were found substantially equivalent via the 510(k) process in K011623. The Orthinox® V40™ femoral head components are fabricated from Orthinox®, a Stainless Steel Alloy conforming to ASTM F1586 and ISO 5832-9. Like the predicate devices, the subject devices are intended for use with femoral stems and acetabular components in primary or revision total hip arthroplasty.
1
Image /page/1/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 and wings.
AUG 2 9 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Debra Bing Regulatory Affairs Manager Howmedica Osteonics Corp. 59 Route17 Allendale, New Jersey 07401
Re: K031730
Trade/Device Name: Addition of 36mm Orthinox® V40™ Femoral Heads to the Exeter Series Regulation Number: 21 CFR 888.3350 Regulation Name: Hip joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JDI Dated: August 5, 2003 Received: August 5, 2003
Dear Ms. Bing:
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 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 A Milken
Celia 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
Indications for Use
510(k) Number (if known):
Device Name: 36mm Orthinox® V40™ Femoral Heads
Indications for Use:
The subject Exeter V40™ Hip System components are intended for use in total hip replacement. They are intended for cemented use only. The subject components are intended for use with any Howmedica Osteonics Corp. acetabular component featuring a polyethylene bearing surface.
Indications:
- Noninflammatory joint disease including osteoarthritis and avascular necrosis, ●
- . Rheumatoid arthritis,
- Correction of functional deformity, ●
- Revision procedures where other treatments or devices have failed, .
- . Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
(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) of Mark N Milkerm (Optional Format 1-2-96)
for
Division Sign-Off)
Division of General, Restorative
and Neurological Devices
510(k) Number _ K031730