(99 days)
No
The device description and intended use are for a ceramic hip replacement component, which is a mechanical device. There is no mention of software, algorithms, or data processing that would suggest the use of AI/ML.
Yes
The device is a component of a total hip replacement, which is a medical procedure used to treat various conditions that cause pain and functional impairment in the hip joint, thus serving a therapeutic purpose.
No
This device is a ceramic head used as a bearing surface in total hip replacement, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a physical ceramic head designed to be the bearing surface of a total hip joint replacement, articulating with a polyethylene liner and attaching to a metallic femoral stem. This is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Description and Intended Use: The description clearly states that the Biolox® delta Ceramic Heads are a component of a total hip replacement. They are implanted inside the body to replace a damaged hip joint.
- Lack of IVD Characteristics: The provided information does not mention any testing of biological samples, analysis of bodily fluids, or any other activity typically associated with IVD devices.
This device is a surgical implant used in orthopedic procedures.
N/A
Intended Use / Indications for Use
Biolox® delta Option Ceramic Heads are indicated 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 above modular heads 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
LZO
Device Description
Biolox® delta Option Ceramic Heads are designed to be the bearing surface of a total hip joint replacement. A highly polished spherical head in a variety of diameters articulates with a polyethylene liner acetabular component. The modular head attaches to a metallic femoral stem via a taper adapter. Adapters are available for either Biomet's Type I taper or Biomet's 12/14 taper in a variety of neck lengths.
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 (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 meet 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.
K042091, K051411, K061312, K073102
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
K082996 (pg 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 font, with the letters connected and a registered trademark symbol. Below the logo, the words "MANUFACTURING CORP" are printed in a simple, sans-serif font.
510(k) Summary
Date: December 8, 2008
JAN 1 5 2009
Applicant/Sponsor: Biomet Manufacturing Corp.
Contact Person: Patricia Sandborn Beres Senior Regulatory Specialist
Proprietary Name: Biolox® delta Option Ceramic Heads
Common or Usual Name: Ceramic Modular Head
Classification Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis
Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Biolox® delta Ceramic Heads - K042091, K051411, K061312, K073102
Device Description: Biolox® delta Option Ceramic Heads are designed to be the bearing surface of a total hip joint replacement. A highly polished spherical head in a variety of diameters articulates with a polyethylene liner acetabular component. The modular head attaches to a metallic femoral stem via a taper adapter. Adapters are available for either Biomet's Type I taper or Biomet's 12/14 taper in a variety of neck lengths.
Indications For Use: Biolox® delta Option Ceramic Heads are indicated 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 above modular heads include:
Mailing Address
Shipping Address:
56 East Bell Drive
Warsaw, IN 46582
1
510(k) Summary 36mm Biolox® delta Option Ceramic Heads Biomet Manufacturing Corp. Page 2
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.
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.
Summary of Technologies: The Biolox® delta Option Ceramic Heads 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 meet for the devices contained in this 510(k).
Clinical Testing: None provided
Biolox is a trademark of CeramTec AG
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Biomet, Inc. % Ms. Patricia Sandborn Beres Senior Regulatory Specialist 56 East Bell Dr. P.O. Box 587 Warsaw, Indiana 46581
JAN 15 2009
Re: K082996
Trade/Device Name: Biolox delta Option Ceramic Heads Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis
Regulatory Class: II Product Code: LZO Dated: December 15, 2008 Received: December 17, 2008
Dear Ms. Beres:
We have reviewed your Section 510(k) premarket notification of intent to market the device We nave reviewed your because is reley per 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 enorolate) to regary actment date of the Medical Device Amendments, or to commerce prior to May 20, 1970, the enaounce with the provisions of the Federal Food. Drug, devices that have been require approval of a premarket approval application (PMA). and Costhere Act (Act) that to hot require appen a controls provisions of the Act. The You may, therefore, market the act include requirements for annual registration, listing of general controls provisions of the 110 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 is classifica (sec above) the exist on on regulations affecting your device can
may be subject to such additional controls. Existing major regulations and sec may be subject to such additional controller Entisting Canyon of Solo to 898. In addition, FDA may be found in the Code of I casial roogening your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that IDA's issualles of a substition with other requirements of the Act
that FDA has made a determination that your device with other requires . You must that FDA nas made a decisimilation administered by other Federal agencies. You must or any Federal statules and regulations daministered of not limited to: registration and listing (21
comply with all the Act's requirements, including, but not limited to: re comply with an the Act s requirements, merceing, which and manufacturing practice requirements as set
3
Page 2 - Ms. Patricia Sandborn Beres
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic (200 10thi in the quality systems (QD) regalsms (Sections 531-542 of the Act); 21 CFR 1000-1050. product faulation control provisions (Seting your device as described in your Section 510(k) This letter whil anow you to begin marketing your antial equivalence of your device to a legally premarket notification: "The PDF interessification 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 If you desire specific advice for your association is (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to (240) 270-0120. This, procese now around of .97). For questions regarding postmarket surveillance, premarket nonneanon (210) It = Liv veillance and Biometric's (OSB's) Division of Postmarket prease contact CDAT 3 Office of Darrensting the reporting of device adverse events Surveillance at (240) 216 317 17103)), please contact the Division of Surveillance Systems (Medical Device Reporting (MDFT)), proacs veral information on your responsibilities under the at (240) 270-5101. Totallay of 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 Millman
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): _ 长沙829966991/1)
Device Name: Biolox® delta Option Ceramic Heads
Indications For Use: Biolox® delta Ceramic Heads are indicated 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 above modular heads 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)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number-
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