(21 days)
Not Found
No
The document describes a mechanical hip stem implant and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is a hip stem intended for use in total hip replacement to reconstruct the hip joint and treat various conditions. This directly aligns with the definition of a therapeutic device, as it is designed to treat or alleviate a medical condition.
No
Explanation: The device is a hip stem intended for surgical replacement (total hip replacement), not for diagnosing conditions.
No
The device description clearly states it is a hip stem, which is a physical implantable device made of TMZF® alloy and coatings. 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 "reconstruction of the head and neck of the femoral joint." This is a surgical implant, not a device used to examine specimens from the human body.
- Device Description: The description details a "femoral stem" which is a physical implant for the hip.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status based on sample analysis
- Reagents, calibrators, or controls
Therefore, this device is a surgical implant and falls under a different regulatory category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The subject hip stem is a single-use device intended for use in total hip replacement. It is intended for the reconstruction of the head and neck of the femoral joint. This hip stem is intended for primary reconstruction of the proximal femur or revision total hip arthroplasty. This device is intended for use with any currently available Howmedica Osteonics acetabular component and V40™ femoral heads that can be mated with a TMZF 5° 40' BG trunnion.
Indications:
- Cementless primary hip surgery in cases of non-inflammatory degenerative joint disease . including osteoarthritis, avascular necrosis, rheumatoid arthritis, and correction of functional deformity.
- Treatment of nonunion, and femoral neck and trochanteric fractures of the proximal femur ● with head involvement that are unmanageable using other techniques.
- Revision procedures where other treatments or devices have failed. ●
Product codes
87 MEH
Device Description
The existing Accolade™ TMZF® HA Hip System features femoral stems in neutral, press-fit versions consisting of a variety of lengths and two neck angles, 132° and 127°. The subject Accolade™ TMZF® Plus HA 127° Size 0 Hip Stem is an addition to the existing hip stems. It features a 127° neck angle and will be offered in an additional size (size 0). The Accolade™ TMZF® Plus HA Size 0 Hip Stem is intended for smaller size patient populations. The subject hip stem, like the predicate hip stems, is manufactured using TMZF® alloy and is also coated with a CP Titanium plasma spray coating and PureFix™ HA.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral 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
Testing was employed to evaluate the Accolade™ TMZF® Plus HA Size 0 Hip Stem component. Testing demonstrated that this hip stem component successfully maintains the proper strength requirements.
Key Metrics
Not Found
Predicate Device(s)
Accolade™ TMZF® Plus HA Hip Stem
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
OCT 0 9 2002
K02 3/02
Line Extension to the Accolade™ Hip System – Accolade™ TMZF® Plus HA 127° Size 0 Hip Stem
Special 510(k) Premarket Notification
Special 510(k) Summary
Line Extension to the Accolade™ Hip System – Accolade™ TMZF® PLUS HA 127° Size 0 Hip Stem
| Proprietary Name: | Accolade™ TMZF® Plus HA 127° Size 0 Hip
Stem |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| 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 |
| Predicate Proprietary Name: | Accolade™ TMZF® Plus HA Hip Stem |
| Predicate Regulatory Class: | Class II |
| Predicate Product Code: | 87 MEH |
| 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 existing Accolade™ TMZF® HA Hip System features femoral stems in neutral, press-fit versions consisting of a variety of lengths and two neck angles, 132° and 127°. The subject Accolade™ TMZF® Plus HA 127° Size 0 Hip Stem is an addition to the existing hip stems. It features a 127° neck angle and will be offered in an additional size (size 0). The Accolade™ TMZF® Plus HA Size 0 Hip Stem is intended for smaller size patient populations. The subject
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hip stem, like the predicate hip stems, is manufactured using TMZF® alloy and is also coated with a CP Titanium plasma spray coating and PureFix™ HA.
Intended Use
The subject hip stem is a single-use device intended for use in total hip replacement. It is intended for the reconstruction of the head and neck of the femoral joint. This hip stem is intended for primary reconstruction of the proximal femur or revision total hip arthroplasty. This device is intended for use with any currently available Howmedica Osteonics acetabular component and V40™ femoral heads that can be mated with a TMZF 5° 40' BG trunnion.
Indications:
- Cementless primary hip surgery in cases of non-inflammatory degenerative joint disease . including osteoarthritis, avascular necrosis, rheumatoid arthritis, and correction of functional deformity.
- Treatment of nonunion, and femoral neck and trochanteric fractures of the proximal femur ● with head involvement that are unmanageable using other techniques.
- Revision procedures where other treatments or devices have failed. ●
Testing Summary
Testing was employed to evaluate the Accolade™ TMZF® Plus HA Size 0 Hip Stem component. Testing demonstrated that this hip stem component successfully maintains the proper strength requirements.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of four stylized human profiles facing right, arranged in a stacked, flowing manner. The profiles are connected and appear to be part of a single, continuous form.
OCT 0 9 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. William J. Cymbaluk Vice President . Quality Assurance, Regulatory Affairs and Clinical Research Stryker Howmedica Osteonics 59 Route 17 South Allendale, N.J. 07401
Re: K023102
Trade/Device Name: Accolade™ TMZF® Plus HA 127° Size 0 Hip Sem 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: MEH Dated: September 17, 2002 Received: September 18, 2002
Dear Mr. Cymbaluk:
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 (OS) 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 - Mr. William J. Cymbaluk
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,
Hyatt Rhodes
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: Line Extension to the Accolade™ Hip System - Accolade™ TMZF® Plus 127° Size 0 Hip Stem
The subject hip stem is a single-use device intended for use in total hip replacement. It is intended for the reconstruction of the head and neck of the femoral joint. This hip stem is intended for primary reconstruction of the proximal femur or revision total hip arthroplasty. This device is intended for use with any currently available Howmedica Osteonics acetabular component and V40™ femoral heads that can be mated with a TMZF 5° 40' BG trunnion.
Indications:
- Cementless primary hip surgery in cases of non-inflammatory degenerative joint disease including . osteoarthritis, avascular necrosis, rheumatoid arthritis, and correction of functional deformity.
- Treatment of nonunion, and femoral neck and trochanteric fractures of the proximal femur with . head involvement that are unmanageable using 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
(Optional Format 1-2-96)
(Per 21 CFR 801.109)
(Division Sign-Off)
Division of General. Restorative
and Neurological Devices
510(k) Number K023102