(11 days)
Not Found
Not Found
No
The document describes a mechanical hip stem and its intended use, materials, and testing, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device, a hip stem, is intended for use in total hip replacement to reconstruct the femoral joint, treating conditions like osteoarthritis and fractures, which directly addresses disease and injury.
No
The device is a hip stem intended for total hip replacement, which is a therapeutic treatment. It is not used for diagnosing medical conditions.
No
The device description clearly describes a physical hip stem made of TMZF® alloy with coatings, intended for surgical implantation. 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 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 derived from the human body.
- Device Description: The description details a "femoral stem" made of alloy and coatings, which is consistent with a surgical implant.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on specimens, or providing diagnostic information based on such analysis.
Therefore, this device falls under the category of a surgical implant or prosthetic device, not an In Vitro Diagnostic device.
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 5° 40' BG taper.
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 (comma separated list FDA assigned to the subject device)
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® HA 132° Size 0 Hip Stem is an addition to the existing hip stems. It features a 132° neck angle and will be offered in an additional size (size 0). The Accolade™ TMZF® 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing was employed to evaluate the Accolade™ TMZF® Size 0 Hip Stem component. Analysis indicates that this hip stem component successfully maintains the proper strength requirements.
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
4 2002 MAR
Line Extension to the Accolade™ Hip System - Accolade™ TMZF® HA 132° Size 0 Hip Stem
K0d0572
page 1 of 2
Special 510(k) Premarket Notification
Special 510(k) Summary
Line Extension to the Accolade™ Hip System - Accolade™ TMZF® HA 132° Size 0 Hip Stem
Proprietary Name: Common Name: Classification Name and Reference:
Accolade™ TMZF® HA 132° Size 0 Hip Stem Artificial Hip Component Hip joint, metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis, 21 CFR §888.3353
Proposed Regulatory Class: Device Product Code:
Predicate Proprietary Name: Predicate Regulatory Class: Predicate Product Code:
For Information contact:
Class II 87 MEH
TMZF® Press Fit HA Stem Class II 87 MEH
Nancy J. Rieder Howmedica Osteonics Corp. 59 Route 17 Allendale, New Jersey 07401-1677 Phone: (201) 934-4364 Fax: (201) 760-8435
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® HA 132° Size 0 Hip Stem is an addition to the existing hip stems. It features a 132° neck angle and will be offered in an additional size (size 0). The Accolade™ TMZF® 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
1
K0205 72
page 2 of 2
Line Extension to the Accolade™ Hip System – Accolade™ TMZF® HA 132° Size 0 Hip Stem
Snecial 510/k) Premarket Notification
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 5° 40' BG taper.
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® Size 0 Hip Stem component. Analysis indicates that this hip stem component successfully maintains the proper strength requirements.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" surrounding the top and bottom portions of the circle. The text is in a sans-serif font and is arranged to follow the curve of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 4 2002
Elizabeth A. Staub Vice President Quality Assurance, Regulatory Affairs and Clinical Research Howmedica Osteonics Corp. 59 Route 17 Allendale, New Jersey 07401-1677
Re: K020572
Trade/Device Name: Accolade TMZF HA 132° Size 0 Hip Stem Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or non-porous uncemented prosthesis Regulatory Class: Class II Product Code: MEH Dated: February 19, 2002 Received: February 21, 2002
Dear Ms. Staub:
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 for the based on 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.
3
Page 2 – Ms. Elizabeth Staub
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter will and w yourse FDA finding of substantial equivalence of your device to a legally promated predicated 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 11 you desire bpoints art 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 011 594-4659. 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 Oiner general 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,
R. Adele M. Wilkerson
ia 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): K020572
Device Name: Line Extension to the Accolade™ Hip System - Accolade™ TMZF® 132° 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 5° 40' BG taper.
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 _ (Per 21 CFR 801.109)
(Optional Format 1-2-96)
for
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
510(k) Number _ K020572