(99 days)
No
The document describes a mechanical implant (Trochanteric Button) and its intended use in hip revision surgery. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance studies are based on non-clinical testing (FEA, cross-section analysis) of the mechanical properties.
Yes
The device, a trochanteric button, is intended for use in total hip arthroplasty revisions and to treat various degenerative joint diseases and fractures, which are therapeutic interventions.
No
The document describes the Arcos Trochanteric Button as a single-use implant used in hip arthroplasty, primarily for reattaching or compressing the greater trochanter. Its purpose is mechanical support and fixation, not to diagnose medical conditions or provide information for a diagnosis.
No
The device description explicitly states it is a "singleuse implant" manufactured from Ti-6Al-4V, indicating it is a physical hardware component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description: The description clearly states the Arcos Trochanteric Button is an implant intended for use in surgical procedures involving the proximal femur. It's a physical component used within the body during surgery.
- Intended Use/Indications for Use: The indications for use describe conditions and procedures related to joint disease, fractures, and revision surgery, all of which are treated surgically, not through laboratory testing of samples.
The device is a surgical implant, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
The Arcos Trochanteric Button is intended for use with the Arcos Modular Femoral Revision System, which is cleared only for uncemented use (K090757), as well as the Arcos Interlocking Stems, a line extension to the Arcos Modular Femoral Revision System, added by Special 510(k) K 100469, listed in the compatible component section.
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 Arcos Modular Femoral Revision System Trochanteric Button hip components are single-use implants, intended for uncemented applications.
Product codes (comma separated list FDA assigned to the subject device)
LPH, LZO, KWZ, JDI, KWY, MAY, MEH, JDG, OQG, OQH, OQI, PBI, LWJ
Device Description
The Arcos Trochanteric Button is being added to the Arcos Modular Femoral Revision System, K090757, to expand surgical options beyond the claw when increased proximal stability is needed, especially when a greater trochanteric osteotomy has been performed. This assembly allows the greater trochanter to be compressed against the prosthesis or for reattaching the greater trochanter in cases where a trochanteric osteotomy has been performed. The Trochanteric Button comes in one size and is manufactured from Ti-6Al-4V. The design is very similar to the cleared Trochanteric Plate cleared for use with the Mallory-Head Modular Calcar System, K031693.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip, proximal femur, greater trochanter
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:
- · Pull-Through Comparison (FEA)
- · Cross Section Analysis
Since the stresses are reduced on the new washer due to the smaller hole and larger contact area, the proposed Arcos Modular Femoral Revision System Trochanteric Button should perform as well or better than the referenced cleared Mallory-Head® Trochanter Plate, thus meeting the acceptance criteria, indicating capability to fulfill surgical expectations.
Clinical Testing:
None provided as a basis for substantial equivalence.
Testing and analysis demonstrates that the modifications made to the Arcos Modular Femoral Revision System, by the addition of the Arcos Trochanteric Button, do not introduce any new risks of safety or efficacy.
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.
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
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.
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K130063 (Page 1 of 3)
APR 1 9 2013
CORP. MANUF
510(k) Summary
Preparation Date:
March 5, 2013
Becky Earl
Regulatory Specialist
Biomet Manufacturing Corp. Phone: (574) 372-1518 Fax: (574) 372-1683 becky.earl@biomet.com
Applicant/Sponsor:
Biomet Manufacturing Corp. 56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581-0587 FDA Registration Number: 1825034
Contact Person:
Proprietary Name:
Arcos Modular Femoral Revision System Trochanteric Button
Common Name:
Trochanteric bolt washer; hip prosthesis accessory
Classification Code(s)/Name(s):
LPH- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented (21 CFR 888.3358)
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)
Matling Address PO Rox 587 Warsaw IN 46581-0587 Toll Free 800 348 9500 Office: 574 267 6639 Main Fax: 574,267,8137 unmat com
ino Address: st Rell Oriva Warsaw, IN 46582
ﺕ ﻳ
1
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)
JDG-Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis (21 CFR 888.3360).
OOG-Prosthesis, hip, semi-constrained, metal/polymer + additive, porous uncemented (21 CFR 888.3358)
OOH-Hip, semi-constrained, cemented, metal/polymer + additive, cemented (21 CFR 888.3350)
OOI-Hip. semi-constrained, cemented, metal/ceramic/polymer + additive, porous uncemented (21 CFR 888.3353)
PBI-Prosthesis, hip, constrained, cemented or uncemented, metal/polymer, + additive (21 CFR 888.3310)
LWJ-prosthesis, hip, semi-constrained, metal/polymer, uncemented (888.3360)
Legally Marketed Devices To Which Substantial Equivalence Is Claimed:
The predicate device is the Biomet Modular Femoral Revision Modular System (Arcos), K090757.
Device Description:
The Arcos Trochanteric Button is being added to the Arcos Modular Femoral Revision System, K090757, to expand surgical options beyond the claw when increased proximal stability is needed, especially when a greater trochanteric osteotomy has been performed. This assembly allows the greater trochanter to be compressed against the prosthesis or for reattaching the greater trochanter in cases where a trochanteric osteotomy has been performed. The Trochanteric Button comes in one size and is manufactured from Ti-6Al-4V. The design is very similar to the cleared Trochanteric Plate cleared for use with the Mallory-Head Modular Calcar System, K031693.
2
Intended Use:
The Arcos Trochanteric Button is intended for use with the Arcos Modular Femoral Revision System, which is cleared only for uncemented use (K090757), as well as the Arcos Interlocking Stems, a line extension to the Arcos Modular Femoral Revision System, added by Special 510(k) K 100469, listed in the compatible component section.
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 Arcos Modular Femoral Revision System Trochanteric Button hip components are singleuse implants, intended for uncemented applications.
Summary of Technologies:
The Arcos Trochanteric Button is being added to the line of accessories for use with the Arcos Modular Femoral Revision System. The Arcos Trochanteric Button uses the same technology as the referenced previously cleared Trochanter Plate included in the Revision Mallory-Head Modular Calcar with and without HA, K031693, which served as a predicate for the Arcos Modular Femoral Revision System. The subject device is manufactured from the same material, conforming to the same standard, as the previously cleared Trochanter Plate.
Non-Clinical Testing:
- · Pull-Through Comparison (FEA)
- · Cross Section Analysis
Since the stresses are reduced on the new washer due to the smaller hole and larger contact area, the proposed Arcos Modular Femoral Revision System Trochanteric Button should perform as well or better than the referenced cleared Mallory-Head® Trochanter Plate, thus meeting the acceptance criteria, indicating capability to fulfill surgical expectations.
Clinical Testing:
None provided as a basis for substantial equivalence.
Testing and analysis demonstrates that the modifications made to the Arcos Modular Femoral Revision System, by the addition of the Arcos Trochanteric Button, do not introduce any new risks of safety or efficacy.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Biomet Manufacturing Corporation % Ms. Becky Earl Regulatory Affairs Specialist P.O. Box 587 Warsaw, Indiana 46581-0587
Letter dated: April 19, 2013
Re: K130063 Trade/Device Name: Arcos Modular Femoral Revision System Trochanteric Button Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: LPH, LZO, KWZ, JDI, KWY, MAY, MEH, JDG, OQG, OQH, OQI, PBI, LWJ Dated: March 22, 2013 Received: March 25, 2013
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 (21
4
Page 2 - Ms. Becky Earl
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/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 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.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known); K130063
Device Name: Arcos Modular Femoral Revision System Trochanteric Button
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 Arcos Modular Femoral Revision System Trochanteric Button hip components are single-use implants, intended for uncemented applications.
Prescription Use (Part 21 CFR 801 Subpart D)
ース アート (1) 【 ( ) 【 ( ) 【 ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( )
AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR 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)
Elizabeth & Erank -S
Division of Orthopedic Devices
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