(67 days)
Not Found
No
The description focuses on the mechanical design and materials of a hip implant, with no mention of AI or ML capabilities.
Yes
The device is a PLR Splined Revision Stem, used for total reconstruction of the hip joint, which is a therapeutic intervention for various medical conditions affecting the hip.
No
The device is a PLR Splined Revision Stem, an implant used in total hip reconstruction surgery. It is a treatment device, not a diagnostic one.
No
The device description clearly states it is a physical implant (a revision stem) made of wrought Titanium, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the PLR Splined Revision Stem is a surgical implant used for the reconstruction of the hip joint. It is a physical device implanted into the body, not a test performed on a sample outside the body.
The information provided describes a medical device used in surgery, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The PLR Splined Revision Stem is indicated for use in patients requiring total reconstruction of the hip joint due to the following:
- a.) Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- b.) Rheumatoid arthritis.
- c.) Correction of functional deformity.
- d.) Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
- e.) Revision of previously failed total hip arthroplasty due to recurrent dislocations.
The PLR Splined Revision Stem is intended for press-fit application for general use in skeletally mature individuals undergoing surgery for rehabilitating hip joints. This device is a single use implant
Product codes
LZO, JDI
Device Description
The PLR Splined Revision Stem is a one-piece, press-fit revision stem machined from wrought Titanium (Ti-6Al-4V). The region above the resection level has a machine finish and the remainder of the stem is a grit blast finished.
The distal portion of the stem has splines. The neck-shaft angle is 135 degrees. The lateral offset for a standard 28mm head is 42mm on all sizes. The stem is 270 mm in length measured from the medial resection level to the distal end. Sizes range from 14mm to 24mm in 1mm increments.
The stem has the standard Biomet, Inc. Type I taper to fit all sizes and types of modular femoral heads. Neck flats are present for stem removal if necessary. The proximal region of the stem has a lateral flare with three holes to use with CoCr cables/wires for attachment of the greater trochanter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint
Indicated Patient Age Range
Skeletally mature individuals
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
SUMMARY OF SAFETY AND EFFECTIVENESS
×994184
SPONSOR:
Biomet, Inc. P.O. Box 587 Airport Industrial Park Warsaw, Indiana 46581-0587
CONTACT PERSON: Tracy J. Bickel
DEVICE NAME: PLR Splined Revision Stem
CLASSIFICATION NAME: Prosthesis, hip, semi-constrained metal/ceramic/polymer, cemented or non-porous uncemented (21 CFR 888.3350)
INTENDED USE:
The PLR Splined Revision Stem is indicated for use in patients requiring total reconstruction of the hip joint due to the following:
- a.) Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- b.) Rheumatoid arthritis.
- c.) Correction of functional deformity.
- d.) Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
- e.) Revision of previously failed total hip arthroplasty due to recurrent dislocations.
The PLR Splined Revision Stem is intended for press-fit application for general use in skeletally mature individuals undergoing surgery for rehabilitating hip joints.
DEVICE DESCRIPTION:
The PLR Splined Revision Stem is a one-piece, press-fit revision stem machined from wrought Titanium (Ti-6Al-4V). The region above the resection level has a machine finish and the remainder of the stem is a grit blast finished.
The distal portion of the stem has splines. The neck-shaft angle is 135 degrees. The lateral offset for a standard 28mm head is 42mm on all sizes. The stem is 270 mm in length measured from the medial resection level to the distal end. Sizes range from 14mm to 24mm in 1mm increments.
The stem has the standard Biomet, Inc. Type I taper to fit all sizes and types of modular femoral heads. Neck flats are present for stem removal if necessary. The P.1/2
1
proximal region of the stem has a lateral flare with three holes to use with CoCr cables/wires for attachment of the greater trochanter.
POTENTIAL RISKS:
The potential risks associated with this device are the same as with any joint replacement device. These include, but are not limited to:
- Fracture of the component Cardiovascular disorders Implant loosening/migration Soft tissue imbalance Deformity of the joint Tissue growth failure Delayed wound healing Metal sensitivity
Bone fracture Hematoma Blood vessel damage Nerve damage Excessive wear Infection Dislocation Breakdown of the porous surface >
SUBSTANTIAL EQUIVALENCE:
Direct comparison was made with the following predicates:
-
- Wagner Revion Stem: K960588 Manufactured by Intermedics (Austin, TX)
-
- Wagner Revisional Femoral Hip Prosthesis: K871347 Manufactured by Protek (Indianapolis, IN)
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, which is a common symbol associated with HHS.
Public Health Service
FEB 1 5 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Tracy J. Bickel Regulatory Specialist Biomet, Inc. Airport Industrial Park P.O. Box 587 Warsaw. Indiana 46581-0587
Re: K994184 Trade Name: PLR Splined Revision Stem Regulatory Class: II Product Code: LZO & JDI Dated: December 7, 1999 Received: December 10, 1999
Dear Ms. Bickel:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Tracy J. Bickel
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, blease note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
/iucil/c-/
- James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page _ of _
510(k) Number (if known): K99 4184 Device Name: PLR Splined Revision Stem Indications for Use:
The PLR Splined Revision Stems is indicated for use in patients requiring total reconstruction of the hip joint due to the following:
- a.) Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- b.) Rheumatoid arthritis.
- c.) Correction of functional deformity.
- d.) Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
- e.) Revision of previously failed total hip arthroplasty due to recurrent dislocations.
The PLR Splined Revision Stem is intended for press-fit application for general use in skeletally mature individuals undergoing surgery for rehabilitating hip joints. This device is a single use implant
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| §10(k) Number | KC994184 |
| Prescription Use | OR | Over-The-Counter Use |
|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) ______ |
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