(24 days)
Not Found
Not Found
No
The document describes a mechanical implant (femoral stem) and its intended use, with no mention of software, algorithms, or data processing that would suggest AI/ML. The performance study focuses on mechanical stress analysis.
Yes
The device is a femoral stem intended for medical conditions like noninflammatory degenerative joint disease, avascular necrosis, rheumatoid arthritis, correction of functional deformity, and treatment of fractures, which categorize it as a therapeutic device.
No
This device is a femoral stem intended for surgical implantation (e.g., hip replacement) to treat joint diseases or fractures, not to diagnose them.
No
The device description clearly states the device is a physical femoral stem made of cobalt chromium alloy, intended for surgical implantation. It is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This is done outside of the body (in vitro).
- Device Description: The provided text describes a femoral stem, which is an implantable device used in hip replacement surgery. It is surgically inserted into the femur (thigh bone).
- Intended Use: The intended use is for treating various conditions affecting the hip joint, such as osteoarthritis, rheumatoid arthritis, and fractures. This is a therapeutic use, not a diagnostic one.
- Lack of IVD Characteristics: The description does not mention any analysis of bodily specimens, diagnostic testing, or any of the typical characteristics of an IVD.
The device described is a surgical implant used for orthopedic procedures.
N/A
Intended Use / Indications for Use
The subject devices are single-use devices intended for use with any currently available Howmedica Osteonics acetabular component, unipolar component, or bipolar component. They may be used with any Howmedica Osteonics cobalt chromium alloy femoral head that can be mated with a 5°40' BG Taper. They may also be used with the Howmedica Osteonics Alumina C-Taper Heads when used with the Adapter Sleeve for V40 to C-Taper Ceramic Head. The devices continue to be compatible with the predicate distal ring centralizers. The femoral stem is intended for cemented fixation.
Indications:
- Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; ●
- Rheumatoid arthritis; ●
- Correction of functional deformity; ●
- Revision procedures where other treatments or devices have failed; and ●
- Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with . head involvement that is unmanageable using other techniques.
Product codes (comma separated list FDA assigned to the subject device)
87 LZO
Device Description
The subject Accolade™ C Femoral Stems are forged from cobalt chromium alloy. They are straight, neutral stems with medial collars. They come in 127° and 132° neck angles. Crescent shaped indentations on the anterior and posterior surfaces provide rotational stability and enhanced mechanical interlock of the cement. The lateral shoulder features a non-threaded hole for connection to an insertion tool. The distal tip of the stems features a recess for optional use with a cement spacer.
The subject Accolade™ C Femoral Stems differ from the predicate Accolade™ C Femoral Stems only in that they feature a recess in the distal tip to allow use with the predicate Howmedica Osteonics Universal Distal Spacers or Universal Distal Hole Plugs. All other design features, materials, and intended uses are the same as for the predicate Accolade™ C Femoral Stems.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Femoral 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)
Analysis of stresses in the subject hip stems was performed to ensure that the incorporation of a distal recess does not adversely affect the integrity of the subject devices.
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.
Not Found
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
Kodd555
AUG 2 6 2002
Special 510(k)
page 1 of 2
Special 510(k) Summary
Modification to Accolade™ C Femoral Stems
| Proprietary Name: | Accolade™ C Femoral Stems |
|---|---|
| Common Name: | Femoral Hip Stems |
| 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 |
| Predicate Proprietary Name(s): | Accolade™ C Femoral Stem |
| Predicate Regulatory Class: | Class II |
| Predicate Product Code(s): | 87 LZO |
| Submitted By: | Howmedica Osteonics Corp. |
| 59 Route 17 | |
| Allendale, New Jersey 07401-1677 | |
| (201) 825-4900 | |
| Contact Information: | Debra Bing |
| Phone: (201) 831-5413 | |
| Fax: (201) 831-6038 | |
| Date Summary Prepared: | August 15, 2002 |
Description/Technological Comparison
The subject Accolade™ C Femoral Stems are forged from cobalt chromium alloy. They are straight, neutral stems with medial collars. They come in 127° and 132° neck angles. Crescent shaped indentations on the anterior and posterior surfaces provide rotational stability and enhanced mechanical interlock of the cement. The lateral shoulder features a non-threaded hole for connection to an insertion tool. The distal tip of the stems features a recess for optional use
1
K022555
page 2 of 2
Special 510(k)
Modification to Accolade™ C. Femoral Stems with a cement spacer.
The subject Accolade™ C Femoral Stems differ from the predicate Accolade™ C Femoral Stems only in that they feature a recess in the distal tip to allow use with the predicate Howmedica Osteonics Universal Distal Spacers or Universal Distal Hole Plugs. All other design features, materials, and intended uses are the same as for the predicate Accolade™ C Femoral Stems.
Intended Use
The subject devices retain the same intended use as the predicate devices. The only difference is that the subject devices feature a distal recess that allows for optional use of the predicate Howmedica Osteonics Universal Distal Spacers and Howmedica Osteonics Universal Distal Hole Plugs.
The subject devices are single-use devices intended for use with any currently available Howmedica Osteonics acetabular component, unipolar component, or bipolar component. They may be used with any Howmedica Osteonics cobalt chromium alloy femoral head that can be mated with a 5°40' BG Taper. They may also be used with the Howmedica Osteonics Alumina C-Taper Heads when used with the Adapter Sleeve for V40 to C-Taper Ceramic Head. The devices continue to be compatible with the predicate distal ring centralizers. The femoral stem is intended for cemented fixation.
Indications:
- Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; ●
- Rheumatoid arthritis; ●
- Correction of functional deformity; ●
- Revision procedures where other treatments or devices have failed; and ●
- Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with . head involvement that are unmanageable using other techniques.
Testing Summary
Analysis of stresses in the subject hip stems was performed to ensure that the incorporation of a distal recess does not adversely affect the integrity of the subject devices.
2
Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services USA. The seal features the department's name in a circular arrangement around a stylized eagle-like symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular pattern. The eagle-like symbol is composed of three curved lines, resembling a bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 .
AUG 2 6 2002
Debra Bing
Regulatory Affairs Manager Howmedica Osteonics Corp. 59 Route 17 Allendale. NJ 07401-1677
Re: K022555
Trade/Device Name: Accolade™ C Femoral Stems Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: Class II Product Code: LZO Dated: August 1, 2002
Received: August 2, 2002
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. Ilsting 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.
3
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 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" (21 CFR 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 vours.
Mark A. Mulhausen
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
4
510(k) Number (if known):
Device Name: Accolade™ C Femoral Stems
The subject devices are single-use devices intended for use with any currently available Howmedica Osteonics acetabular component, unipolar component, or bipolar component. They may be used with any Howmedica Osteonics cobalt chromium alloy femoral head that can be mated with a 5°40' BG Taper. They may also be used with the Howmedica Osteenics Alumina C-Taper Heads when used with the Adapter Sleeve for V40 to C-Taper Ceramic Heads. The femoral stem is intended for cemented fixation.
Indications:
- Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; .
- Rheumatoid arthritis; ●
- Correction of functional deformity; .
- Revision procedures where other treatments or devices have failed; and ●
OR
- 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 >
Over-The-Counter Use (Per 21 CFR 801.109) (Optional Format 1-2-96)
Mark N Millhenser
eral. Restorative and Neurologi
510(k) Number.
Cl