(59 days)
No
The document describes a ceramic hip implant component and its intended use, without mentioning any software, algorithms, or data processing that would involve AI or ML.
Yes
The device is a component of a total hip replacement, used to treat various conditions like degenerative joint disease, rheumatoid arthritis, fractures, and for revision procedures. These indications clearly define it as a device intended to treat or alleviate a disease or injury, thus qualifying it as a therapeutic device.
No
The device is a ceramic head component for total hip replacement, used for treatment and revision procedures, not for diagnostic purposes.
No
The device description clearly states it is a modular ceramic head and adapter sleeve, which are physical components for hip replacement surgery. There is no mention of software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes the device as a component for total hip replacement surgery. It is used to replace damaged parts of the hip joint in patients with various conditions affecting the hip. This is a surgical implant, not a diagnostic test performed on biological samples.
- Device Description: The description details a modular ceramic head designed to articulate within a hip joint prosthesis. It describes the material and how it connects to other components of the hip replacement system. This is a physical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to test biological samples (blood, urine, tissue, etc.) or to provide information about a patient's health status based on such testing. The device's function is purely mechanical and structural within the body.
Therefore, the Biolox® delta Option Ceramic Heads are a surgical implant, not an In Vitro Diagnostic device.
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, avascular necrosis and traumatic arthritis.
-
- Rheumatoid arthritis.
-
- Correction of functional deformity.
-
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanaqeable 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)
Product codes (comma separated list FDA assigned to the subject device)
LZO, LPH, OQG, LWJ, JDI, OQH, OQI, MAY
Device Description
The Biolox® delta Option component is a modular ceramic head with a Type I or 12/14 adapter sleeve, indicated for primary or revision hip arthroplasty. The material for the device is Transition-Toughened-Platelet Alumina (TTPA) 75% Alumina, 24% Zirconia and 1% Platelet. The highly polished spherical surface articulates with a polyethylene liner acetabular component. The modular head attaches to any Biomet metallic femoral stem with a Type 1 taper or a 12/14 taper, using the associated adapter sleeve. There have been no changes in design or part numbers since the original submission in K082996 and K093549 (size 44mm).
The scope of this submission is to incorporate Biomet's entire Biolox® deta Option Ceramic Heads under unified part numbers, Indications and Contraindications, Instructions for Use, labeling and packaging.
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)
No additional mechanical testing was conducted since there are no design changes to the device since clearance, K082996 and K093549.
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.
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized depiction of human profiles facing right, with three distinct faces layered on top of each other. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 18, 2014
Biomet. Inc. Ms. Becky Earl Senior Regulatory Affairs Specialist 56 East Bell Drive, P.O. Box 587 Warsaw, Indiana 46581-0587
Re: K141653
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: Class II Product Code: LZO, LPH, OQG, LWJ, JDI, OQH, OQI, MAY Dated: May 28, 2014 Received: June 20, 2014
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 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
1
(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 (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education 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,
Lori A. Wiggins -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
K141653 510(k) Number (if known):
Device Name: Biolox® delta Option Ceramic Heads
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, avascular necrosis and traumatic arthritis.
-
- Rheumatoid arthritis.
-
- Correction of functional deformity.
-
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanaqeable 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 mav compromise the fixation and stability of a standard-type hip replacement prosthesis. (K990830, K042774)
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)
Page 1 of 1
3
510(k) Summary
| Preparation Date: | May 28, 2014 |
|---|---|
| Sponsor: | Biomet UK Ltd. |
| Waterton Industrial Estate | |
| Bridgend, South Wales, UNITED KINGDOM CF31 3XA | |
| FDA Registration Number: 9044936 | |
| Telephone: +44(0) 1656 655221 | |
| Correspondent | Biomet Manufacturing Corp. |
| 56 East Bell Drive | |
| P.O. Box 587 | |
| Warsaw, IN 46581-0587 | |
| Establishment Registration Number: 1825034 | |
| Telephone: (574) 267-6639 | |
| Contact Person: | Becky Earl |
| Senior Regulatory Specialist | |
| Proprietary Name: | Biolox® delta Option Ceramic Heads |
| Common Name: | Femoral Modular Ceramic Head |
| Classification Name: | LZO-Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented |
| or Non-Porous, Uncemented (21 CFR 888.3353) | |
| LPH-Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | |
| (21 CFR 888.3358) | |
| OQG-Prosthesis, hip, semi-constrained, metal/polymer + additive, porous | |
| uncemented (21 CFR 888.3358) | |
| LWJ-prosthesis, hip, semi-constrained, metal/polymer, uncemented | |
| (21 CFR 888.3360) | |
| JDI- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | |
| (21 CFR 888.3350) | |
| OQH-Hip, semi-constrained, cemented, metal/polymer + additive, cemented | |
| (21 CFR 888.3350) |
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 E Bell Drive Warsaw, IN 46582
4
OQI-Hip, semi-constrained, cemented, metal/ceramic/polymer + additive, porous uncemented (21 CFR 888.3353)
MAY—Prosthesis.hip. semi-constrained. metal/ceramic/polymer.cemented or non-porous cemented, osteophilic finish (21 CFR 888.3353)
Legally Marketed Devices To Which Substantial Equivalence Is Claimed:
- Biolox® delta Option Ceramic Heads —Biomet—K082996 .
- 44mm E1 Acetabular Liner with 44mm Biolox® delta Option Ceramic Head or 44mm M2a Magnum Modular Head - Biomet-K093549
- . Biolox® delta Ceramic Heads Taper change and Global Product Line —Biomet—K131684
Device Description:
The Biolox® delta Option component is a modular ceramic head with a Type I or 12/14 adapter sleeve, indicated for primary or revision hip arthroplasty. The material for the device is Transition-Toughened-Platelet Alumina (TTPA) 75% Alumina, 24% Zirconia and 1% Platelet. The highly polished spherical surface articulates with a polyethylene liner acetabular component. The modular head attaches to any Biomet metallic femoral stem with a Type 1 taper or a 12/14 taper, using the associated adapter sleeve. There have been no changes in design or part numbers since the original submission in K082996 and K093549 (size 44mm).
The scope of this submission is to incorporate Biomet's entire Biolox® deta Option Ceramic Heads under unified part numbers, Indications and Contraindications, Instructions for Use, labeling and packaging.
Indications for Use:
Biolox® delta Option Ceramic Heads are indicated for use in total hip replacement with cemented or noncemented femoral and acetabular components in cases of:
-
- Non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis and traumatic arthritis.
-
- Rheumatoid arthritis.
-
- Correction of functional deformity.
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur 4. 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)
5
Summary of Technologies:
The technological characteristics of the Biolox® delta Option Ceramic Heads are the predicates. K082996 and K093549. There have been no changes to the devices since their original clearance, other than the addition of traumatic arthritis to the Indications for Use and a change in packaging to the configuration used in K131684.
Non-Clinical Testing:
No additional mechanical testing was conducted since there are no design changes to the device since clearance, K082996 and K093549.
Clinical Testing:
None provided as a basis for substantial equivalence.
There are no modifications to the originally cleared device other than the inclusion of traumatic arthritis to the Indications for Use and a change in packaging to conform to that used in the Biolox delta Ceramic Heads, K131684 thus no new risks of safety or efficacy have been introduced. The Biolox® delta Option Ceramic Heads remain substantially equivalent to the predicates and raise no new issues of safety or efficacy.