(28 days)
No
The summary describes a mechanical implant with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is an acetabular component designed to treat various joint diseases, fractures, and deformities, which are therapeutic interventions.
No
This device is an acetabular component for hip replacement surgery, used for treatment of joint diseases and fractures, not for diagnosing conditions.
No
The device description clearly states it is a "hemispherical metallic acetabular cup" and mentions physical components like a modular hook, ilium flange, ischial blade, and porous/HA coating, indicating it is a physical implant, not software.
No, 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, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description: The provided description clearly states that the PAR 5 Acetabular Component is a hemispherical metallic acetabular cup intended for surgical implantation in the hip joint.
- Intended Use: The intended uses listed are all related to the surgical treatment of various hip joint conditions, such as osteoarthritis, rheumatoid arthritis, and fractures.
This device is a surgical implant, not a diagnostic test performed on a sample outside the body.
N/A
Intended Use / Indications for Use
The indications for the PAR 5 Acetabular component are as follows:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- Rheumatoid arthritis
- Correction of functional deformity
- Treatment of nonunion, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques
- Revision procedures where other treatment or devices have failed
Product codes
JDI, LPH
Device Description
The PAR 5 Acetabular Component is a hemispherical metallic acetabular cup, which can accept a modular hook, ilium flange, and/or a modular ischial blade. The shell accepts a standard Ringloc® liner. The outer surface of the shells has porous coating. The shells are also available with or without hydroxyapatite (HA) coating.
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
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
Non-Clinical Testing: Substrate testing with an Engineering Justification determined that the modified PAR 5 Acetabular Components presented no new risks and were, therefore, substantially equivalent to the predicated device.
Clinical Testing: None provided as a basis for substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
PAR 5 Acetabular Components- K000254
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
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JUL 2 5 2002
KQ22094
page 1 of 1
SUMMARY OF SAFETY AND EFFECTIVE
| Sponsor: | Biomet, Inc. |
|---|---|
| 56 East Bell Drive | |
| P.O. Box 587 | |
| Warsaw, IN 46581-0587 |
- Contact Person: Tracy J. Bickel (574) 267-6639
Proprietary Name: PAR 5 Acetabular Components
Common Name: Acetabular Component(s)
Hip joint metal/polymer semi-constrained cemented prosthesis (888.3350) Classification Name:
Substantially Equivalent Devices: PAR 5 Acetabular Components- K000254
Device Description: The PAR 5 Acetabular Component is a hemispherical metallic acetabular cup, which can accept a modular hook, ilium flange, and/or a modular ischial blade. The shell accepts a standard Ringloc® liner. The outer surface of the shells has porous coating. The shells are also available with or without hydroxyapatite (HA) coating.
The indications for the PAR 5 Acetabular Component(s) are as follows: Indications:
-
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
-
- Rheumatoid arthritis
- Correction of functional deformity 3)
- Treatment of nonunion, femoral neck fractures, and trochanteric fractures of the proximal 4) femur with head involvement, unmanageable using other techniques
-
- Revision procedures where other treatment or devices have failed
Summary of Technologies: Hydroxyapatite coated implants and an additional ilium flange are being added to the current PAR 5 System. The PAR 5 Acetabular Components- the material's, design, sizing, and indications are identical to the predicate device(s).
Non-Clinical Testing: Substrate testing with an Engineering Justification determined that the modified PAR 5 Acetabular Components presented no new risks and were, therefore, substantially equivalent to the predicated device.
Clinical Testing: None provided as a basis for substantial equivalence.
All trademarks are property of Biomet, Inc.
1
Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of three human figures in profile, facing to the right, with three parallel lines above them.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 5 2002
Ms. Tracy J. Bickel Regulatory Specialist Biomet Orthopedics, Inc. P.O. Box 587 Warsaw, Indiana 46581-0578
Re: K022094
Trade/Device Name: PAR 5 Acetabular Component Regulation Number: 21 CFR §888.3350 Regulation Name: Hip joint metal/polymer metal semi-constrained cemented prosthesis and Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II
Product Code: JDI and LPH Dated: June 24, 2002 Received: June 27, 2002
Dear Ms. Bickel;
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.
2
Page 2 - Ms. Tracy J. Bickel
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.
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.qov/cdrh/dsma/dsmamain.html
Sincerely yours.
for Mark M. Milkins
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
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Page 1 of 1
510(k) Number (if known): Device Name: PAR 5 Indications for Use:
The indications for the PAR 5 Acetabular component are as follows:
- Non-inflammatory degenerative joint disease including osteoarthritis and 1) avascular necrosis
- Rheumatoid arthritis 2)
-
- Correction of functional deformity
- Treatment of nonunion, femoral neck fractures, and trochanteric fractures of 4) the proximal femur with head involvement, unmanageable using other techniques
- Revision procedures where other treatment or devices have failed ર)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Mark A. Millers
al. Restorative
s k, ur
K 022
Over-The-Counter Use (Optional Format 1-2-96)
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