(29 days)
No
The document describes a line extension for hip replacement components (acetabular liners and femoral heads) and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is an acetabular liner and ceramic head for use in total hip replacement, which is a therapeutic intervention for various joint diseases, fractures, and deformities.
No
The device is an acetabular liner and ceramic head for total hip replacement, which are medical implants, not diagnostic tools.
No
The device description clearly indicates it is a physical medical device (acetabular liner and ceramic/metal heads) used in total hip replacement surgery, not a software-only product.
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 used in the body for total hip replacement. IVDs are used outside the body to examine specimens (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The description details components of a hip implant (liner and head), not a test or reagent used for analyzing biological samples.
- Anatomical Site: The anatomical site is the hip, indicating an implantable device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
This device is a medical device (specifically, an orthopedic implant), but it is not an IVD.
N/A
Intended Use / Indications for Use
The 44mm E1™ Acetabuler Liner with 44mm Biolox® delta Option Ceramic Head or 44mm Mra Magnum™ Modular Head is for use in total hip replacement with cemented or non-cemented femoral and acetabular components in cases of:
-
- 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 by other techniques.
-
- Revision procedures where other treatment or devices have failed.
Specific indications for compatible components that can be used with the 44mm Biolox® delta Option Ceramic Head include:
Salvage/Oncology Hip and Total Femur System components are also indicated for cases of ligament deficiency, tumor resection, trauma and revision of unsuccessful osteotomy or arthrosis. (K974558, K002757, K021380, K033871)
Interlocking hip stems are indicated for non-cemented application in cases of revision, trauma, fracture, oncology or other situations where severe proximal bone loss may compromise the fixation and stability of a standard-type hip replacement prosthesis. (K990830. K042774)
Product codes (comma separated list FDA assigned to the subject device)
LZO, LPH, JDI, LWJ, MAY
Device Description
Biomet Manufacturing Corp. is addinq a size 44mm liner to their line of E1™ Acetabular Liners to allow the surgeon more options. Additionally, the 44mm Biolox® delta Option Ceramic Head is added to the ceramic option line. The 44mm M²a Magnum™ may be used when a Co-Cr-Mo option is needed. This submission is a line extension of the previously cleared systems.
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: All parameters of the "Guidance Document for the Preparation of PreMarket Notifications for Ceramic Ball Hip Systems" were met for the devices contained in this 510(k).
Clinical Testing: None provided
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.
K974558, K002757, K021380, K033871, K990830, K042774
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
Image /page/0/Picture/0 description: The image shows a handwritten string of characters and numbers. The string begins with the letters "K0", followed by the numbers "93549". After the numbers, there is a symbol that looks like an asterisk followed by a number sign. The string ends with the fraction "1/2".
Image /page/0/Picture/1 description: The image shows the logo for Biomet Manufacturing Corp. The logo consists of the word "BIOMET" in a stylized, blocky font, with the words "MANUFACTURING CORP." printed in a simpler font below. A small trademark symbol is located to the right of the word "BIOMET".
DEC 1 6 2009
510(k) Summary
November 16, 2009 Date:
Biomet Manufacturing Corp. Applicant/Sponsor:
Becky Earl Contact Person: Requlatory Specialist
44mm E1™ Acetabular Liner* with 44mm Biolox® delta Proprietary Name: Option Ceramic Head or 44mm M-a Maqnum™ Modular Head (* also known as E-Poly™ Acetabular Liners)
Common or Usual Name: UHMWPE Liners
Classification Name:
- 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);
- MAY-prosthesis, hip, semi-constrained, metal/ceramic/ . Polymer, cemented or non-porous cemented, osteophilic finish (888.3353);
- LZO-prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented . or non-porous, uncemented (888.3353)
Legally Marketed Devices To Which Substantial Equivalence Is Claimed:
100 kGy E-Poly™ Acetabular Liners – K070399 and K090103, Biolox® delta Option Ceramic Heads - K082996.
Device Description: Biomet Manufacturing Corp. is addinq a size 44mm liner to their line of E1™ Acetabular Liners to allow the surgeon more options. Additionally, the 44mm Biolox® delta Option Ceramic Head is added to the ceramic option line. The 44mm M²a Magnum™ may be used when a Co-Cr-Mo option is needed. This submission is a line extension of the previously cleared systems.
Mailing Address:
P.O. Box 587
Warsaw, IN 46581-0587
Toll Free: 800.348.9500
Office: 574.267.6639
Main Fax: 574.267.8137
www.biomet.com
Shipping Address:
56 East Bell Drive
Warsaw, IN 46582
1
K093549*#/2
510(k) Summarv
44mm E1™ Acetabular Liner* with 44mm Biolox® delta Option Ceramic Head or 44mm M2a Magnum™ Modular Head Biomet Manufacturing Corp. Page 2
Indications For Use: The 44mm E1™ Acetabular Liners are for use in total hip replacement with cemented or non-cemented femoral and acetabular components in cases of:
-
- 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 by other techniques.
-
- Revision procedures where other treatment or devices have failed.
Specific indications for compatible components that can be used with the Biolox® delta Option Ceramic Head include:
Salvage/Oncology Hip and Total Femur System components are also indicated for cases of ligament deficiency, tumor resection, trauma and revision of unsuccessful osteotomy or arthrosis. (K974558, K002757, K021380, K033871)
Interlocking hip stems are indicated for non-cemented application in cases of revision, trauma, fracture, oncology or other situations where severe proximal bone loss may compromise the fixation and stability of a standard-type hip replacement prosthesis. (K990830, K042774)
Summary of Technologies: The 44mm E1™ Liner and 44mm Biolox® delta Option Ceramic Head are technologically similar to the predicate devices.
Non-Clinical Testing: All parameters of the "Guidance Document for the Preparation of PreMarket Notifications for Ceramic Ball Hip Systems" were met for the devices contained in this 510(k).
Clinical Testing: None provided
Biolox is a trademark of CeramTec AG
2
Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three overlapping wing segments, symbolizing health, services, and people. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
DEC 1 6 2009
Biomet Manufacturing Corp. % Ms. Becky Earl P.O. Box 587 Warsaw, Indiana 46581-0587
Re: K093549
Trade/Device Name: 44mm E1™ Acetabular Liner with 44mm Biolox® delta Option Ceramic Head or 44mm M2a Magnum Modular Head Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: Class II Product Code: LZO, LPH, JDI, LWJ, MAY Dated: November 16, 2009 Received: November 17, 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 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
3
Page 2 - Ms. Becky Earl
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Survcillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Omitti 78
Image /page/3/Picture/7 description: The image contains a handwritten letter 'j' on the left side. On the right side, there are three lines of text, with the first line starting with a bullet point. The text is not clear enough to be read.
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):_KOS13SH9
Device Name: 44mm E1™ Acetabular Liner with 44mm Biolox® delta Option Ceramic Head or 44mm M2a Magnum™ M Modular Head
Indications For Use: The 44mm E1™ Acetabuler Liner with 44mm Biolox® delta Option Ceramic Head or 44mm Mra Magnum™ Modular Head is for use in total hip replacement with cemented or non-cemented femoral and acetabular components in cases of:
-
- 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 by other techniques.
-
- Revision procedures where other treatment or devices have failed.
Specific indications for compatible components that can be used with the 44mm Biolox® delta Option Ceramic Head include:
Salvage/Oncology Hip and Total Femur System components are also indicated for cases of ligament deficiency, tumor resection, trauma and revision of unsuccessful osteotomy or arthrosis. (K974558, K002757, K021380, K033871)
Interlocking hip stems are indicated for non-cemented application in cases of revision, trauma, fracture, oncology or other situations where severe proximal bone loss may compromise the fixation and stability of a standard-type hip replacement prosthesis. (K990830. K042774)
Prescription Use X (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)
Soutu for mxm
(Division Sign c.f)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K093549
Page 1 of 1