(27 days)
Not Found
No
The summary describes a physical medical device (hip implant components) and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is described as addressing various joint diseases, fractures, and for revision of failed arthroplasty, all of which aim to restore or improve physiological function.
No
The device description and intended use indicate it is an implant (hip arthroplasty components) used for treatment, not for diagnosing medical conditions.
No
The device description clearly states it is adding "new +3 MaxRom™ and +3 Hi-Wall profiles" which are physical components (acetabular liners) for hip arthroplasty. This is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. They are used to diagnose diseases, conditions, or states of health.
- This device is an implantable medical device. It is a hip replacement component designed to be surgically implanted into a patient's body to treat various hip conditions.
The description clearly indicates a surgical implant for treating anatomical issues, not a device for testing biological samples.
N/A
Intended Use / Indications for Use
-
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- Rheumatoid arthritis. 2.
- Correction of functional deformity. 3.
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the র্থ proximal femur with head involvement, unmanageable using other techniques.
- Revision of previously failed total hip arthroplasty. นว่
Cemented and Uncemented Applications
Product codes (comma separated list FDA assigned to the subject device)
MAY, LZO, LWJ, JDI, LPH
Device Description
Biomet Manufacturing Corp. is adding new +3 MaxRom™ and +3 Hi-Wall profiles to bevice Description Liomet Handracumy to allow the surgeon an option for achieving more range of motion and joint stability in smaller patients.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip
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)
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 (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
K090103 (pg 1/2)
Image /page/0/Picture/1 description: The image shows a logo with the word "BIOMET" in a stylized font. The letters are outlined with a rough, textured edge, giving them a three-dimensional appearance. The overall design is simple and bold, with a focus on readability and visual impact. The logo appears to be for a company named "BIOMET".
FEB 11 2009
510(k) Summary
January 13, 2009 Preparation Date:
Biomet Manufacturing Corp. Applicant/Sponsor:
Contact Person: Becky Earl
MANUFA
Proprietary Name: 100 kGy E-Poly™Acetabular Liners- Additional Profiles: +3 MaxRom™ and +3 Hi-Wall
Common Name: UHMWPE Liners
Classification Name(s):
- LPH- prosthesis, hip, semi-constrained, metal/polymer, porous uncemented (888.3358); �
- JDI- prosthesis, hip, semi-constrained, metal/polymer, cemented (888.3350); �
- LWJ- prosthesis, hip, semi-constrained, metal/polymer, uncemented (888.3360); g
- MAY- prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous 0 cemented, osteophilic finish (888.3353)
- LZO- prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, o uncemented (888.3353)
Legally Marketed Devices To Which Substantial Equivalence Is Claimed: K070399, 100 kGy E-Poly™ Acetabular Liners-Additional Profiles
Device Description: Biomet Manufacturing Corp. is adding new +3 MaxRom™ and +3 Hi-Wall profiles to bevice Description Liomet Handracumy to allow the surgeon an option for achieving more range of motion and joint stability in smaller patients.
Intended Use:
-
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- Rheumatoid arthritis. 2.
- Correction of functional deformity. 3.
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the র্থ proximal femur with head involvement, unmanageable using other techniques.
- Revision of previously failed total hip arthroplasty. นว่
Cemented and Uncemented Applications
Summary of Technologies: The intended use, indications and materials of the subject Summary of Treennoniges o its predicate counterpart, with the exception of the additional profiles. The components forflain now act it is cross-linked polyethylene in acetabular applications are adequately supported sarely and chectiveness of the erass innou paterials data, and testing results provided within this Premarket Notification.
Mailing Address: P.O. Box 597 Warran, IN 46531-0587 Toll Free: 800,348,9500 stay bloadel com
Shipping Aidress: 56 East Dell Driva Wasser 11 20552
1
.K090103 (pg 2/2)
510(K) Notification Biomet Manufacturing Corp. Blomet Manafaccaring of artistics of articles: +3 MaxRom™ and +3 Hi-Wall Page 2 of 2
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.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes on its wing, representing the department's commitment to health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Biomet, Inc. % Ms. Becky Earl Regulatory Specialist 56 East Bell Drive P.O. Box 587 Warsaw, IN 46581
Re: K090103
Trade/Device Name: 100kGy E-Poly Acetabular Liners - Additional Profiles; +3 MaxRom™ and +3 Hi-Wall
FEB 1 1 2009
Regulation Number: 21 CFR 888.3353
Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prothesis
Regulatory Class: Class II
Product Code: MAY, LZO, LWJ, JDI, LPH
Dated: January 13, 2009
Received: January 15, 2009
Dear Ms. Earl:
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.
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
3
Page 2 - Ms. Becky Earl
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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Wilkerson
Mark N. Melkerson 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): K090103 (ps 1/1)
Device Name: 100kGy E-Poly™ Acetabular Liners-Additional Profiles: +3 MaxRom™ and +3 Hi-Wall
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 falled total hip arthroplasty.
Cemented and Uncemented Applications (as based on mating shell)
YES Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use NO (21 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)
Mirle H. Milken
Page 1 of 1
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number.