(29 days)
Not Found
No
The document describes a physical medical device (femoral heads for hip replacement) and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is a component of a total hip system used in arthroplasty, which is a surgical procedure to restore function to a joint, inherently having a therapeutic purpose.
No
The device is a component of a total hip system used for arthroplasty, which is a surgical procedure to replace a joint, not to diagnose a condition.
No
The device description clearly states it is a physical component (femoral head) made of Cobalt Chromium Alloy, intended for surgical implantation. 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 that these are "modular components of a total hip system" for use in "primary or revision total hip arthroplasty." This describes a surgical implant used in vivo (within the body) during a medical procedure.
- Device Description: The description reinforces this by detailing the material (Cobalt Chromium Alloy) and its function as a "femoral head component" for use with other hip replacement components.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
Therefore, this device falls under the category of a surgical implant or prosthetic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
These devices are modular components of a total hip system. These femoral heads are intended for use with femoral stems and acetabular components in primary or revision total hip arthroplasty.
Product codes (comma separated list FDA assigned to the subject device)
JDI, LWJ, KWY
Device Description
This Special 510(k) submission is intended to add 36mm V40™ femoral head components in -5mm, +0mm, +5mm and +10mm offsets to the LFIT™ and non-LFFTTM Femoral Bearing Series. The intended use, manufacturing methods, materials, packaging and sterilization of the subject device are identical to those of predicate devices. The V40™ femoral head components are fabricated from Cobalt Chromium Alloy conforming to ASTM F1537. 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
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Anatomical Site
Hip Joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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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.
K010757, K936126, K950541, K993601
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
JUL 2 5 2002 -
Special 510(k) Summary - Addition of 36mm V40™ Femoral Heads To The LFIT™ And Non-LFIT™ Series
| SUBJECT DEVICE | PREDICATE DEVICE | |
|---|---|---|
| Proprietary Name: | 36mm V40TM Femoral Head | |
| Components (LFITTM and Non- | ||
| LFITTM) | 22mm-32mm V40TM Femoral Head | |
| Components (LFITTM and Non- | ||
| LFITTM) | ||
| 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, LWJ, KWY | (87) JDI, LWJ, KWY |
| 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: | June 14. 2002 |
This Special 510(k) submission is intended to add 36mm V40™ femoral head components in -5mm, +0mm, +5mm and +10mm offsets to the LFIT™ and non-LFFTTM 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 LFIT™ V40™ femoral bearing components were found substantially equivalent via the 510(k) process in K010757. The non-LFIT™ V40™ femoral head components were cleared in 510(k) numbers: K936126, K950541, and K993601. The V40™ femoral head components are fabricated from Cobalt Chromium Alloy conforming to ASTM F1537. Like the predicate devices, the subject devices are intended for use with femoral stems and acetabular components in primary or revision total hip arthroplasty.
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Image /page/1/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in a bold, serif font. The words are arranged on a single line and centered.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Jennifer A. Daudelin Regulatory Affairs Howmedica Osteonics Corporation 59 Route 17 Allendale, New Jersey 07401-1677
JUL 2 5 2002
Re: K022077
Trade/Device Name: 36mm V40™ Femoral Head Components (LFIT™ and Non-LFIT™) Regulation Number: 21 CFR 888.3350 and 888.3390
Regulation Name: Hip Joint Metal/Polymer Semi-Constrained Cemented Prosthesis and Hip Joint Femoral (Hemi-Hip) Metal/Polymer Cemented or Uncemented Prosthesis Regulatory Class: Class II Product Code: JDI, LWJ, and KWY Dated: June 25, 2002 Received: June 26, 2002
Dear Ms. Daudelin:
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.
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Page 2 - Ms. Jennifer A. Daudelin
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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.
O Mark N Milliken
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
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Indications for Use
510(k) Number (if known): K022077
Device Name: 36mm V40™ Femoral Heads
Indications for Use:
These devices are modular components of a total hip system. These femoral heads are intended for use with femoral stems and acetabular components in primary or revision total hip arthroplasty.
R. Mark N. Milken
ion Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K022077
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)