(186 days)
Not Found
No
The summary describes a mechanical implant system and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a Biomet® Modular Revision Femoral System, used for treating various joint diseases and fractures, and for revision of failed hip arthroplasty, which are all therapeutic interventions.
No
This device is a Biomet® Modular Revision Femoral System, specifically described as a "comprehensive, press-fit revision stem design" intended for surgical implantation to revise previously failed total hip arthroplasty or treat other femoral conditions. Its purpose is to correct functional deformities and replace bone, not to diagnose medical conditions or identify diseases.
No
The device description clearly states it is a "comprehensive, press-fit revision stem design" and includes "modular proximal and distal bodies," "proximal bodies," and "auxiliary implants," all of which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The Biomet® Modular Revision Femoral System is described as a "press-fit revision stem design" and "single-use implants." It is a physical implant intended for surgical use within the body.
- Intended Use: The intended uses listed are all related to surgical procedures for treating conditions affecting the femoral bone and hip joint.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory testing.
Therefore, the Biomet® Modular Revision Femoral System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Indications for the Biomet® Modular Revision Femoral System Include:
-
- Noninflammatory 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.
The Biomet® Modular Revision Femoral System hip components are single-use implants, intended for uncemented applications.
Product codes (comma separated list FDA assigned to the subject device)
KWA, LPH, JDL, LZO, KWZ, JDI, KWY, MAY and MEH
Device Description
The Blomet® Modular Revision Femoral System is a comprehensive, press-fit revision stem design that provides the surgeon with multiple styles of modular proximal and distal bodies for reconstruction of various defects commonly seen in femoral revision surgery. The proximal bodies will consist of broached, calcarreplacing, and cone-style implants. The system also includes auxiliary implants to aid in fixation. A single set of instrumentation is provided for all styles. The system is intended for uncemented applications
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon
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 laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use.
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.
K031693, K042774, K013106, K022549, K994038
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
§ 888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.
(a)
Identification. A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two-part 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 includes prostheses that consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027).(b)
Classification. Class III.(c)
Date PMA or notice of completion of PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 18, 2016, for any hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976, or that has, on or before May 18, 2016, been found to be substantially equivalent to a hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976. Any other hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
Image /page/0/Picture/1 description: The image shows the word "GIOMET" in a stylized, blocky font. The letters are outlined and filled with a pattern of small squares or dots, giving them a textured appearance. The overall design is simple and geometric, with a focus on the shape and form of the letters.
MANUFACTURING CORP.
SEP 2 5 2009
510(k) Summary
Preparation Date:
March 20, 2009
Applicant/Sponsor:
Biomet Manufacturing Corp.
56 East Bell Drive P.O. Box 587 Warsaw, IN 46581-0587 Establishment Registration Number: 1825034
Contact Person:
Becky Earl Regulatory Specialist
Proprietary Name:
Common Name:
Classification Name:
Biomet® Modular Femoral Revision System
Femoral Hip Revision System
LPH- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porqus Uncemented (21 CFR 888.3358)
KWA-Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) (21 CFR 888.3330)
JDL- Prosthesis, Hip, Semi-Constralned (Metal Cemented Acetabular Component) (21 CFR 888.3320)
LZO-Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented (21 CFR 888,3353)
KWZ-Prosthesis, Hip, Constrained, Cemented or Uncemented, Metal/Polymer (21 CFR 888.3310)
JDI- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented (21 CFR 888.3350)
KWY-Prosthesis, Hip, Hemi-Femoral, Metal/Polymer, Cemented or Uncemented (21 CFR 888.3390)
MAY-Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous Cemented, Osteophilic Finish (21 CFR 888.3353)
MEH-Prosthesis, Hip, Semi-constrained, Uncemented, Metal/Polymer, Non-Porous, Calcium-Phosphate (21 CFR 888.3353)
Meiling Address: నిల్, విశ్ల క్యక్రిక Wargan 8 48 381-0587 To Frate (200 Manders) 0180 541 267 165 1488 Fax: 574 20208137 ານປະຈິນ.Eວັນຕ່ອງໂດຍນາງ:
Shipping Address: 险会到 到10月份 Warst July 46582
1
Legally Marketed Devices To Which Substantial Equivalence Is Claimed:
| K031693 | Mallory-Head® Modular Calcar with and without HA—Biomet |
|---|---|
| K042774 | Mallory-Head® Modular Calcar Stems with Interlocking Slots-Blomet |
| K013106, K022549 | Restoration™ Modular System—Stryker |
| K994038 | Modular Reach® Hip--Biomet |
Device Description:
The Blomet® Modular Revision Femoral System is a comprehensive, press-fit revision stem design that provides the surgeon with multiple styles of modular proximal and distal bodies for reconstruction of various defects commonly seen in femoral revision surgery. The proximal bodies will consist of broached, calcarreplacing, and cone-style implants. The system also includes auxiliary implants to aid in fixation. A single set of instrumentation is provided for all styles. The system is intended for uncemented applications
Intended Use:
Indications for the Biomet® Modular Revision Femoral System Include:
-
- Noninflammatory 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.
The Blomet® Modular Revision Femoral System hip components are single-use implants, intended for uncemented applications.
Summary of Technologies:
The Biomet® Modular Revision Femoral System has the same technological haracteristics as the predicates listed above.
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.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Biomet Manufacturing Corp. % Ms. Becky Earl Regulatory Affairs Specialist P.O. Box 587 Warsaw, Indiana 46581-0587
SEP 2 5 2009
Re: K090757
Trade/Device Name: Biomet® Modular Femoral Revision System Regulation Number: 21 CFR 888.3330 Regulation Name: Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis Regulatory Class: III Product Code: KWA, LPH, JDL, LZO, KWZ, JDI, KWY, MAY and MEH Dated: September 19, 2009 Received: September 21, 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 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.
3
Page 2 - Ms. Becky Earl
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/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 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Hamil Clary
FOR
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): K090757
Device Name: Biomet® Modular Femoral Revision System
Indications For Use:
-
- Noninflammatory 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.
The Biomet® Modular Revision Femoral System hip components are single-use implants, intended for uncemented applications.
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)
Jonita for MKN
This sign off
(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices
510(k) Number K090757
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