(12 days)
Not Found
No
The summary describes a mechanical hip stem and its intended use and modifications. There is no mention of any software, algorithms, or data processing that would indicate the presence of AI or ML.
No
This device, a hip stem, is an implant used in total hip replacement surgery for reconstruction of the femoral joint, which falls under the category of a medical device rather than a therapeutic device in the sense of delivering therapy.
No
The device is a hip stem intended for total hip replacement, specifically for reconstructive surgery of the femoral joint, not for diagnosing conditions.
No
The device description clearly states it is a "femoral stem," which is a physical implant used in hip replacement surgery. It is made of TMZF® alloy and features coatings. 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 from the human body to provide information for diagnosis, monitoring, or compatibility.
- Device Description: The description details a "femoral stem" made of alloy, which is a physical implant.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process related to in vitro testing.
The device described is a surgical implant used in orthopedic procedures.
N/A
Intended Use / Indications for Use
- Cementless primary hip surgery in cases of non-inflammatory degenerative joint disease . including ostcoarthritis, 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, 87 LZO
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® RPS Hip Stem is a modification to the existing hip stems. It features a reduction in the area of Commercially Pure Titanium (CP-Ti) plasma spray and PureFixTM HA coatings on I body of the stem. The subject hip stem, like the predicate hip stems, is ured using TMZF® alloy.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
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
Image /page/0/Picture/0 description: The image is a black and white abstract design. The left side of the image is solid black, while the right side is white. There is a transition area between the black and white, where the black gradually fades into white with a speckled effect.
SEP 2 7 2005
Image /page/0/Picture/2 description: The image contains the names of three companies: Stryker, Howmedica, and Osteonics. The text is black and the background is white. The names are stacked vertically, with Stryker at the top, Howmedica in the middle, and Osteonics at the bottom. The font is bold and easy to read.
325 Corporate Drive
Mahwah, NJ USA 07430
510(k) Summary of Safety and Effectiveness for the Accolade® RPS Femoral Stem
Proprietary Name:
Common Name:
Classification Name and Reference
Regulatory Class:
Device Product Code:
For Information contact:
Accolade® RPS Femoral Stem
Total Hip Joint Replacement Prosthesis
Hip joint, metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prostheses, 21 CFR §888.3353
Class II
87 MEH - prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calciumphosphate,
87 LZO - prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
Tiffani Rogers Regulatory Affairs Specialist Stryker Orthopaedics 325 Corporate Drive Mahwah, New Jersey 07430 Phone: (201) 831-5412 Fax: (201) 831-6038 E-Mail: Tiffani.Rogers@stryker.com
Date Summary Prepared:
September 13, 2005
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® RPS Hip Stem is a modification to the existing hip stems. It features a reduction in the area of Commercially Pure Titanium (CP-Ti) plasma spray and PureFixTM HA coatings on
Image /page/0/Picture/22 description: The image shows a black and white abstract pattern. The pattern is concentrated in the lower left corner and extends upwards. The pattern is made up of small, irregular shapes and lines.
$\frac{1}{2}$
1
I body of the stem. The subject hip stem, like the predicate hip stems, is ured using TMZF® alloy.
ended Use:
The subject hip stem is a single-use, sterile device intended for use in total hip replacement. It is The subject imp stem is a = = =
intended for the reconstruction of the head and neck of the femoral joint. This hip stem is intended for the reconstruction of the proximal femur or revision total hip arthroplasty. This intended for primary
device is intended for use with any currently available Howmedica Osteonics acetabular device is miches.
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 . Cententess primary inf varseular 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. .
Substantial Equivalence:
The determination of the substantial equivalence of the Accolade® RPS hip stem is based on its similarities in intended use, design and sterilization to the Accolade® TMZF® femoral stem (K994366, cleared March 16, 2000). Predicate device information is located in Appendix E.
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2
Image /page/2/Picture/1 description: The image contains the text 'Public Health Service'. The text is in a simple, bold font and is horizontally aligned. The background is plain and white, which makes the text stand out.
Image /page/2/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The seal is encircled by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in a circular arrangement.
SEP 27 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Tiffani D. Rogers Regulatory Affairs Specialist Stryker Howmedica Osteonics Corporation 325 Corporate Drive Mahwah, New Jersey 07430
Re: K052542 Trade/Device Name: Accolade® RPS Hip Stem 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: LZO, MEH Dated: September 14, 2005 Received: September 15, 2005
Dear Ms. Rogers:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becternined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreate) to regions the Medical Device Amendments, or to commerce prior to May 20, 1976, in ecordance with the provisions of the Federal Food, Drug, devices mat have been reculise in assess as as a proval of a premarket approval application (PMA). and Cosmetic Act (71ct) that to not request in the general controls provisions of the Act. The 1 ou may, merelore, mains of the Act include requirements for annual registration, listing of general controls provisions of tractice, 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 If your device is classified (see aberty) als. Existing major regulations affecting your device can may be subject to saterial 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 r rease oe avrised has i termination that your device complies with other requirements of the Act that I DA has made a and regulations administered by other Federal agencies. You must of uny I odelul states and we wents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set OFF 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. Tiffani D. Rogers
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter witi anow you to begin mantening of substantial equivalence of your device to a legally premarket nothleanon. The PDA maing of cacommand of 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 If you desire specific advice for Jour do 110-76-0120. Also, please note the regulation entitled, p Colliact the Office of Complance at (1) + + = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = Misoranting by release to premainters in the Act from the Division of Small other general international and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Mark A. Millerson
Mark N. Melkerson Acting 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): | |
|---|---|
| Device Name: | Accolade® RPS Hip Stem |
Indications for Use
Indications
-
Cementless primary hip surgery in cases of non-inflammatory
-
Cementless primary hip surgery in cases of non-inflammatory degenerative joint disease . including ostcoarthritis, 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. .
Prescription Use X
OR Over-the-Counter Use (Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark D. Milliken
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number