(76 days)
Accolade™ TMZF® HA Hip Stems and Accolade™ TMZF® HA Plus Hip Stems, Omnifit® M-HA Hip Stems
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No
The document describes a hip stem implant and its intended use, materials, and performance testing (FEA). There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
Yes
The device is a hip stem intended for primary reconstruction of the proximal femur or revision total hip arthroplasty to treat various conditions, which aligns with the definition of a therapeutic device.
No
Explanation: The device described is a hip stem, which is an implant used for reconstruction of the proximal femur or revision total hip arthroplasty. Its purpose is to replace or support the hip joint, not to diagnose a medical condition.
No
The device description clearly states it is a hip stem, which is a physical implantable device made of material with specific geometry and coating. This is a hardware 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 clearly describes a surgical implant for the hip joint, used for primary reconstruction or revision total hip arthroplasty. This is a therapeutic device, not a diagnostic one.
- Device Description: The description focuses on the physical characteristics and materials of a hip stem, which is an implantable device.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (like blood, urine, tissue), providing diagnostic information, or being used in a laboratory setting.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is a physical implant used to replace or support a damaged joint.
N/A
Intended Use / Indications for Use
The subject hip stems are single-use devices intended for cementless fixation. They are intended for primary reconstruction of the proximal femur or revision total hip arthroplasty. These devices are intended for use with any currently available Howmedica Osteonics acetabular component and V40 femoral heads labeled for use with V40 Titanium stems. The indications for use remain identical to those of the predicate devices, and are restated here.
Indications:
- Non-inflammatory degenerative 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, and 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)
87 MEH, LZO
Device Description
The subject Accolade™-J Hip Stems feature the geometry of the predicate TMZF® HA Hip Stems and Accolade™ TMZF® Plus HA Hip Stems, but feature the same substrate material and same HA coating as the predicate Omnifit® M-HA Hip Stems.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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
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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)
Finite Element Analysis (FEA) was used to evaluate the strength of the neck and body regions of the subject Accolade™-J Hip Stems.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
Accolade™ TMZF® HA Hip Stems and Accolade™ TMZF® HA Plus Hip Stems, Omnifit® M-HA Hip Stems
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
032300
Accolade™-J Hip Stem Series
ﻴ
510(k) Premarket Notification
OCT - 9 2003
510(k) Summary
Accolade™-J Hip Stem Series
| Proprietary Name: | Accolade™-J Hip Stem Series |
|---|---|
| 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 MEH, LZO |
| Predicate Proprietary Name: | Accolade™ TMZF® HA Hip Stems and Accolade™ |
| TMZF® HA Plus Hip Stems | |
| Omnifit® M-HA Hip Stems | |
| Predicate Regulatory Class: | Class II |
| Predicate Product Code: | 87 MEH |
| For Information contact: | Lorraine Montemurro |
| Howmedica Osteonics Corp. | |
| 59 Route 17 | |
| Allendale, New Jersey 07401-1677 | |
| Phone: (201) 831-5892 | |
| Fax: (201) 831-6038 | |
Description/Technological Comparison
The subject Accolade™-J Hip Stems feature the geometry of the predicate TMZF® HA Hip Stems and Accolade™ TMZF® Plus HA Hip Stems, but feature the same substrate material and same HA coating as the predicate Omnifit® M-HA Hip Stems.
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Intended Use
The subject hip stems are single-use devices intended for cementless fixation. They are intended for primary reconstruction of the proximal femur or revision total hip arthroplasty. These devices are intended for use with any currently available Howmedica Osteonics acetabular component and V40® femoral heads labeled for use with V40® Titanium stems. The indications for use remain identical to those of the predicate devices, and are restated here.
Indications:
- Non-inflammatory degenerative 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, and femoral neck and trochanteric fractures of the proximal femur . with head involvement that are unmanageable using other techniques.
Testing Summary
Finite Element Analysis (FEA) was used to evaluate the strength of the neck and body regions of the subject Accolade™-J Hip Stems.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. Inside the circle is an abstract image of an eagle with three stripes representing the agency's mission to protect the health of all Americans and provide essential human services.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 9 2003
Ms. Lorraine Montemurro Regulatory Affairs Manager Howmedica Osteonics Corp. 59 Route 17 Allendale, NJ 07401-1677
Re: K032300
Trade/Device Name: Accolade™-J Hip Stem Series 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: MEH and LZO Dated: July 24, 2003 Received: August 6, 2003
Dear Ms. Montemurro:
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. Lorraine Montemurro
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 vours.
Sincerely yours,
for Mark N. Milken
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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510(k) Number (if known): _Ko32308
Device Name: Accolade™-J Hip Stem Series
The subject hip stems are single-use devices intended for cementless fixation. They are intended for primary reconstruction of the proximal femur or revision total hip arthroplasty. These devices are intended for use with any currently available Howmedica Osteonics acetabular component and V40® femoral heads labeled for use with V40® Titanium stems. The indications for use remain identical to those of the predicate devices, and are restated here for ease of reference.
Indications:
- Non-inflammatory degenerative 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, and 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) (Optional Format 1-2-96)
Mark N Milken
I. Restorative
510(k) Number K032300