(10 days)
There are no predicate devices listed in the text. The "Predicate Device(s)" section explicitly states "Not Found".
Not Found
No
The description focuses on the mechanical design and materials of a physical implant, with no mention of software, algorithms, or data processing.
No.
The device description indicates it is an acetabular component (a hip implant), which is a medical device used for structural support and replacement within the body, not for therapy or treatment of disease itself.
No
The device is an acetabular component intended for surgical implantation to treat various hip joint conditions, not for diagnosing them.
No
The device description clearly details a physical, metallic acetabular component with various attachments and fabrication materials, indicating it is a hardware medical device.
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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that the Par 5 Acetabular Component is a surgical implant designed to be placed within the hip joint. It is a physical component used to replace or augment damaged bone in the hip.
- Intended Use: The intended uses listed are all related to treating conditions affecting the hip joint through surgical intervention.
- No Mention of Samples or Testing: There is no mention of the device being used to analyze samples from the body or perform any kind of diagnostic test.
Therefore, the Par 5 Acetabular Component is a medical device, specifically a surgical implant, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
- Noninflammatory degenerative joint disease including osteoarthritis and avascular 1) necrosis
- Rheumatoid arthritis 2)
- Correction of functional deformity 3)
- Correction of functional delomity
Treatment of nonunion, femoral neck fractures, and throchanteric fractures of the 4) i reatment of nonunion, femoral neon nactaros, and the sing other techniques - proximal remar with neath joint construction or treatment 5)
Product codes
JDI
Device Description
The Par 5 Acetabular Component is a hemispherical metallic acetabular Device Description: The Par 5 Aceladular Oomponent on rim. The shell has six cup with a hook, flange and/or blade extending from the contabular component. cup with a hook, flange and/or blace extending to a traditional acetabular component. holes for placement of 6.5mm cancellous screws similar to a traditional and blade compon holes for placement of 6.5mm carcellous screws simman of the hook and blade components Additionally, the shell has three counterbores for attachment of the hook a standard Hi Additionally, the shell has three counterbores for attachment of the illustian and Biomet and a mounting flange for attachment of the ilium flange. The shell accepts a stand Ring-loc liner.
The forked illum flange is available in three sizes: small, medium and large and in left, right and in The forked illum frange is available in three stace. Smally houldned to the flange is a straight configurations. Screw noles and more of the sheaped the patient's malleable and can be shaped by the surgeon in the will on the shall of the shall at the mounting anatomy to provide additional support. The ilium flange is attached to the m flange by the component geometry and screw fasteners.
The malleable hook is placed within one of the counterbores of the shell in a position where it will The malleable nook is placed within one of the outler of the one of the one
reside beneath the teardrop of the ishium. The hook is formed to the patient's anatomy by the reside benefit is held to the shell by a screw.
The blade component is intended to enter the ishium bone in a manner similar to a sceve. The she The blade component is mended to enter the ishis not of this component is held to the shell
curvature of the blade resembles the curvature of the component is held to the she curvature of the blade roosmbles the out secondarily, by a screw.
The illum flange and hook are fabricated from commercially pure (CP) titanium. The cup and The illum flange and hook are fabricated from tommontally por (e. 7) P. (e. 7) F-136. The outer
blade are fabricated from titanium alloy (Ti-6Al-4) conformances blade are labhoutou from the shell with titanium plasma spray.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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.
0
Image /page/0/Picture/2 description: The image shows the logo for Biomet Inc. The logo is in black and white and features the word "BIOMET" in a bold, sans-serif font. The letters are connected to each other, and the "T" is stylized with a square around it. Below the logo, the words "CORPORATE HEADQUARTERS" are printed in a smaller, sans-serif font.
SUMMARY OF SAFETY AND EFFECTIVENESS
Sponsor: Biomet, Inc.
Contact Person: Patricia Sandborn Beres
Trade Name: Par 5 Acetabular Component
Classification Name: Hip joint metal/polymer semi-constrained cemented prosthesis (21 CFR 8883350)
Indications for Use:
- for Use:
Noninflammatory degenerative joint disease including osteoarthritis and avascular 1) necrosis - Rheumatoid arthritis 2)
- Correction of functional deformity 3)
- Correction of functional delomity
Treatment of nonunion, femoral neck fractures, and throchanteric fractures of the 4) i reatment of nonunion, femoral neon nactaros, and the sing other techniques - proximal remar with neath joint construction or treatment 5)
Device Description: The Par 5 Acetabular Component is a hemispherical metallic acetabular Device Description: The Par 5 Aceladular Oomponent on rim. The shell has six
cup with a hook, flange and/or blade extending from the contabular component. cup with a hook, flange and/or blace extending to a traditional acetabular component.
holes for placement of 6.5mm cancellous screws similar to a traditional and blade compon holes for placement of 6.5mm carcellous screws simman of the hook and blade components
Additionally, the shell has three counterbores for attachment of the hook a standard Hi Additionally, the shell has three counterbores for attachment of the illustian and Biomet
and a mounting flange for attachment of the ilium flange. The shell accepts a stand Ring-loc liner.
The forked illum flange is available in three sizes: small, medium and large and in left, right and in The forked illum frange is available in three stace. Smally houldned to the flange is a straight configurations. Screw noles and more of the sheaped the patient's malleable and can be shaped by the surgeon in the will on the shall of the shall at the mounting
anatomy to provide additional support. The ilium flange is attached to the m flange by the component geometry and screw fasteners.
The malleable hook is placed within one of the counterbores of the shell in a position where it will The malleable nook is placed within one of the outler of the one of the one
reside beneath the teardrop of the ishium. The hook is formed to the patient's anatomy by the reside benefit is held to the shell by a screw.
The blade component is intended to enter the ishium bone in a manner similar to a sceve. The she The blade component is mended to enter the ishis not of this component is held to the shell
curvature of the blade resembles the curvature of the component is held to the she curvature of the blade roosmbles the out secondarily, by a screw.
The illum flange and hook are fabricated from commercially pure (CP) titanium. The cup and The illum flange and hook are fabricated from tommontally por (e. 7) P. (e. 7) F-136. The outer
blade are fabricated from titanium alloy (Ti-6Al-4) conformances blade are labhoutou from the shell with titanium plasma spray.
MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587
1
SHIPPING ADDRESS Airport Industrial Park Warsaw, IN 46580
$\frac{1}{2}$
OFFICE 219.267.6639
FAX
219.267.8137
E-MAIL biomet@biomet.com
1
Potential Risks: The potential risks associated with this device are the same as with any other total joint replacement device. These include, but are not limited to:
Reaction to the bone cement Deformity of the joint Cardiovascular disorders Fracture of the cement Implant loosening/migration Break down of the porous surface Blood vessel damage Soft tissue imbalance Delayed wound healing Metal sensitivity Fracture of the component Excessive wear
Bone fracture Infection Hematoma Dislocation Nerve damage
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
7 2000 FEB
Ms. Patricia Sandborn Beres Senior Regulatory Specialist Biomet, Inc. P.O. Box 587 Warsaw, Indiana 46581-0587
Re: K000254
Trade Name: PAR 5 Acetabluar Component Regulatory Class: II Product Code: JDI Dated: January 27, 2000 Received: January 28, 2000
Dear Ms. Beres:
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 above and we have assemment in interstate commerce prior to May 28, 1976, the stated in the encreater) to the Medical Device Amendments, or to devices that have been reclassified in eccordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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.
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.
3
Page 2 - Ms. Patricia Sandborn Beres
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) 594-4659. 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 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 at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Russell Sayre
E. Dill, III
Sames E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radioloģical Health
Enclosure
4
510(k) Number (if known): KOOOZ SY
Device Name: Par 5 Acetabular Component
Indications For Use:
The indications for the Par 5 Acetabular Component are as follows:
-
- Noninflammatory 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 of failed total joint construction or treatment
(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 K 900259 510(k) Number
Prescription Use
X
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
00007