(230 days)
Not Found
No
The summary describes a modification to the manufacturing process of a polyethylene component for hip implants. There is no mention of software, algorithms, image processing, or any terms related to AI or ML.
Yes
The device is described as an acetabular component for hip replacement, and its intended uses include treating various joint diseases and fractures, which are medical conditions, making it a therapeutic device.
No
The description indicates the device is a modified polyethylene component for hip arthroplasty, treating existing conditions like osteoarthritis and fractures. It is a therapeutic implant, not something used to diagnose a medical condition.
No
The device description clearly states it is a modification to the manufacturing process of a physical component (polyethylene acetabular components) used in hip arthroplasty. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device for surgical implantation to treat various hip joint conditions. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a modified polyethylene material for use in acetabular components (part of a hip implant). This is a medical device intended for implantation, not for testing samples from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Indications For Use:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- Rheumatoid arthritis.
- Correction of functional deformity.
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
- Revision of previously failed total hip arthroplasty.
Cemented and Uncemented Applications
Product codes
LPH, JDI, LWJ, MAY
Device Description
Biomet Manufacturing Corp. is modifying the manufacturing process of ultra-high molecular weight polyethylene (UHMVPE) used in the fabrication of polyethylene. The modified manufacturing process results in a higher cross-linked UHMWPE. The highly cross-linked UHMWPE is infused with medical grade Vitamin E.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip 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
Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use.
Clinical Testing: None provided as a basis for substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.
0
K050327 page '98
SEP 2 7 2005
BIOMET
510(k) Summary
| Sponsor: | Biomet Manufacturing Corp.
P.O. Box 587
Warsaw, IN 46581-0587 |
|-----------------|---------------------------------------------------------------------------------------------------|
| Contact Person: | Tracy Bickel Johnson, RAC
Regulatory Associate
Biomet Manufacturing Corp.
(574) 267-6639 |
Vitamin E Acetabular Liners (E-Poly™) Proprietary Name:
Common Name: UHMWPE Liners
prosthesis, hip, semi-constrained, metal/polymer, cemented (888.3350);
comented on Classification Name(s): prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or
prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemi-constrained prosthesis, hip, semi-constrained, mictainsis, hip, semi-constrained,
non-porous, uncemented (888.3353); prosthesis, hip, semi-constrained, non-porous, uncemented (606.355); prosultsion inp.
uncemented metal/ polymer, non-porous, calcium phosphate (888.3358); uncemented metal/ polymer, non-porous, ourner, porous (888.3358);
prosthesis, hip, semi-constrained, metal/polymer, porous (888.3358); prosthesis, hip, semi-constrained, metal, polymer, por, while has and (888.3358)
Substantially Equivalent Devices: -ArCom® Polyethylene Liners and Components (K023357)
- Arcon Polyers - - Binch - Binch - - Bingl -RingLoc® 36mm Liners (K032396)
Device Description: Biomet Manufacturing Corp. is modifying the manufacturing process of ultra-high Device Description: Biomet Manufacturing Corp. Is modifylene acetabular components.
molecular weight polyethylene (UHMVPE) used in the fabrication of polyethylene. The high molecular weight polyethylene (UHWVP) dised in the fabrication of polyethylene. The highly cross-linked
The modified manufacturing process results in a higher cross-linked p UHMWPE is infused with medical grade Vitamin E.
Indications for Use:
- tions for Use:
Non-inflammatory degenerative joint disease including osteoarthritis and avascular 1) necrosis. - Rheumatoid arthritis. 2)
- Correction of functional deformity. 3)
- Correction of functional delomity.
Treatment of non-union, femoral neck fracture, and trochanteric fractures of the 4) Treatment of non-unfor, remoral neck itserent, unmanageable using other techniques.
proximal femur with head involvement, unmanageable using other techniques.
The management, - Revision of previously failed total hip arthroplasty. 5)
Cemented and Uncemented Applications
MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587 SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582
100
OFFICE 574.267.6639
FAX 574.267.8137
E-MAIL biomet@biomet.com
1
page 2 of 8
.
510(k) Summary- Page 2 of 3 910(K) Manufacturing, Corp. Blomet Manufacturing, 2017
Vitamin E Acetabular Liners (E-Poly™)
| Summary of Technologies: | The intended use, indications, contraindications, and design specifications of the subject components remain identical to their predicate component counterparts. The raw material being utilized in the manufacture of both the subject and the predicate devices remains a ultra-high molecular weight polyethylene (UHMWPE) per ASTM F-648. The modifications to the manufacturing process of this polyethylene will be introduced in order to create a higher cross-linked polyethylene. The safety and effectiveness of this cross-linked polyethylene in acetabular applications, as well as the proposed wear claims, are adequately supported by the substantial equivalence information, materials data, and testing results provided within this Premarket Notification. |
|---|---|
| Non-Clinical Testing: | Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use. |
| Clinical Testing: | None provided as a basis for substantial equivalence. |
All trademarks are property of Biomet, Inc.
,
・
:
·
and the comments of the comments of
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three stripes extending from its head, representing health, services, and human needs. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.
Public Health Service
SEP 2 7 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Tracy Bickel Johnson, RAC Regulatory Associate Biomet Manufacturing Corporation 56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46582
Re: K050327
Trade/Device Name: E-Poly™ Acetabular Liners Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: II Product Code: LPH, JDI, LWJ, MAY Dated: July 27, 2005 Received: July 28, 2005
Dear Ms. Johnson:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed 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 encreations of the enactment date of the Medical Device Amendments, or to conimered pror to riay 2011-11-11 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). and Cosmetic For (110) in the device, subject to the general controls provisions of the Act. The r ou may, ateres, and on of the Act include requirements for annual registration, listing of general controls profice, 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 to such additional controls. Existing major regulations affecting your device can may or sations to dates the 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 i that FDA has made a determination that your device complies with other requirements of the Act that I Dr Has Intatutes and regulations administered by other Federal agencies. You must of any I edetar statutes and states and the mot limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set OF N Fart 677), accems (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. Tracy Bickel Johnson, RAC
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will allow you to begin marketing your actres of your device of your device to a legally
premarket notification. The FDA finding of substantial equivaleond thus, premarket notification. The FDA Inding of substantial equivaliation of your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
rst led If you desire specific advice for your de not one of a cases note the regulation entitled,
contact the Office of Compliance at (240) 276-0120. contact the Office of Compliance at (240) 270 of the PR Part 807.97). You may obtain
"Misbranding by reference to premarket notification" (214) at first the Division of Sma "Misbranding by relerence to premarkst noutheation" (1993 from the Division of Small
other general information on your responsibilities under the Act from pumber (800) 638-20 other general information on your responsionites at its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its toll-idemanan httpl Manufacturers, International and Consultion Pressource agov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark Milliken
Mark N. Melkerson Acting Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation . Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: E-Poly™ Acetabular Liners
Indications For Use:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular 1) necrosis.
-
- Rheumatoid arthritis.
-
- Rheumatold aframational deformity.
-
- Correction of functional deformity.
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the
- Treatment of non-union, femoral neck rracture, and dochanteriories with the more of the manager.
proximal femur with head involvement, unmanageable using other techniques.
Th proximal remur with nead involvanians, 5) Revision of previously.
- Revision of previously failed total hip arthroplasty.
Cemented and Uncemented Applications
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
er-The-Counter Use
(CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark M. Millman
(Division Sign-Off) (Division Sigand Neurological Devices
510(k) Number_