(116 days)
No
The document describes a mechanical implant and associated instrumentation, with no mention of AI/ML terms, image processing, or data-driven performance metrics.
Yes
The device is intended for the treatment of various medical conditions such as degenerative joint disease, rheumatoid arthritis, correction of functional deformity, and treatment of non-union/fractures, which are therapeutic applications.
No
The device is described as a "femoral stem component in hip replacement surgery" and is used for "total hip and hemi hip arthroplasty." It is an implant used for treatment, not for diagnosing a condition.
No
The device description explicitly states it is a "femoral stem component in hip replacement surgery" and includes "implant specific instrumentation," indicating it is a physical implant and associated tools, not software.
No, 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 provided text describes a surgical implant (a femoral stem component for hip replacement surgery). This is a device that is surgically placed inside the body.
- Intended Use: The intended uses listed are for treating conditions affecting the hip joint through surgical intervention, not through laboratory testing of samples.
The information clearly indicates this is a medical device used in surgery, not a diagnostic test performed outside the body.
N/A
Intended Use / 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 procedures where other treatment or devices have failed.
The Arcos One-Piece Femoral Revision System hip components are single-use implants, intended for uncemented use only.
Product codes (comma separated list FDA assigned to the subject device)
LPH, LZO, KWL, LWJ, KWZ, JDI, OQG, OQH, OQI, PBI, KWY
Device Description
The Arcos One-piece Femoral Revision System is to be used as a femoral stem component in hip replacement surgery. The system is designed for both primary and revision total hip and hemi hip arthroplasty. All implants included in this system are intended for single use only. The system also includes implant specific instrumentation for all stem variants.
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 Tests:
- Femoral Stem Fatigue
- Range of Motion
Clinical Tests:
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.
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure in profile, with three overlapping faces suggesting a sense of community and support. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the figure, emphasizing the department's role and national scope. The logo is simple, yet conveys a sense of care and public service.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 6, 2015
Biomet Incorporated % Mr. Paul Cutlan Regulatory Affairs Manager (Hips) Waterton Industrial Estate Bridgend. Bridgend CF31 3XA UNITED KINDOM
Re: K151603 Trade/Device Name: Acros One-piece Femoral Revision System 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, KWL, LWJ, KWZ, JDI, OQG, OQH, OQI, PBI, KWY Dated: September 15, 2015 Received: September 17, 2015
Dear Mr. Cutlan:
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 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
1
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 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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K151603
Device Name
Arcos One-piece Femoral Revision System
Indications for Use (Describe)
-
- 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 procedures where other treatment or devices have failed.
The Arcos One-Piece Femoral Revision System hip components are single-use implants, intended for uncemented use only.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the word "BIOMET" in a bold, sans-serif font. The letters are all capitalized and evenly spaced. The color of the text is dark gray, and the background is white. The overall impression is clean and modern.
510(k) Summary
In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the Arcos One-piece Femoral Revision System 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on August 12, 2005.
| Sponsor: | Biomet Manufacturing Corp.
56 East Bell Drive
PO Box 587
Warsaw, IN 46581-0857
Phone Number: (574) 267-6639
Fax Number: (574) 371-1027
Establishment Registration Number: 1825034 |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Paul Cutlan
Regulatory Affairs Manager |
| Date: | October 2nd 2015 |
| Subject Device: | Trade Name: Arcos One-piece Femoral Revision System
Common Name: Hip Prosthesis |
| | Classification Name: |
| | ●
LPH - Hip joint metal/polymer/metal semi-constrained porous-coated
uncemented prosthesis (21 CFR 888.3358) |
| | ●
LZO - Hip joint metal/ceramic/polymer semi-constrained cemented or
nonporous uncemented prosthesis (21 CFR 888.3353) |
| | ●
KWL - Hip joint femoral (hemi-hip) metallic cemented or uncemented
prosthesis (21 CFR 888.3360) |
| | ●
LWJ - Hip joint femoral (hemi-hip) metallic cemented or uncemented
prosthesis (21 CFR 888.3360) |
| | ●
KWZ - Hip joint metal/polymer constrained cemented or uncemented
prosthesis (21 CFR 888.3310) |
| | ●
JDI - Hip joint metal/polymer semi-constrained cemented prosthesis (21 CFR 888.3350) |
4
Image /page/4/Picture/0 description: The image shows the word "BIOMET" in all caps. The letters are a dark gray color and are in a simple, sans-serif font. The letters are evenly spaced and the word is centered in the image. The background is white.
- . OQG - Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis (21 CFR 888.3358)
- OQH - Hip joint metal/polymer semi-constrained cemented prosthesis (21 CFR 888.3350)
- OQI - Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis (21 CFR 888.3353)
- . PBI – Hip joint metal/polymer constrained cemented or uncemented prosthesis (21 CFR 888.3310)
- KWY - Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis (21 CFR 888.3390)
Legally marketed device(s) to which equivalence is claimed:
Reference Devices:
Labeling and Biocompatibility:
-
· K143009 Echo Bi-Metric Microplasty Hip Stem (Biomet).
Implant Materials/Instrument materials/Type I taper Trunnion: -
K150503 Echo Bi-Metric Microplasty Line Extension (Biomet).
Implant Stem Diameters: -
K070274 Echo Bi-Metric Press Fit Stems (Biomet).
Device Description:
The Arcos One-piece Femoral Revision System is to be used as a femoral stem component in hip replacement surgery. The system is designed for both primary and revision total hip and hemi hip arthroplasty. All implants included in this system are intended for single use only. The system also includes implant specific instrumentation for all stem variants.
Intended Use and Indications for Use:
-
- Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
5
-
- Rheumatoid arthritis.
- Correction of functional deformity. 3.
-
- Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
-
- Revision procedures where other treatment or devices have failed.
The Arcos One-piece Femoral Revision System hip components are single-use implants, intended for uncemented use only.
Summary of Technical Characteristics:
The rationale for substantial equivalence is based on consideration of the following:
- The technological characteristics of the Arcos One-piece Femoral Revision System are the same as those of predicate devices (K090757 and K000760) in terms of design, material, and principle of operation with the exception of slight modifications as described within the 510(k).
- . The Arcos One-piece Femoral Revision System is a monolithic variant of the Modular Femoral Revision System (Arcos) (K090757). Like the modular system, the Arcos Onepiece is designed as a porous-coated femoral stem available in multiple lengths and proximal bodies for primary and revision procedures.
Summary of Performance Data (Non-clinical and/or Clinical) :
Non-clinical Tests:
- Femoral Stem Fatigue
- Range of Motion
Clinical Tests:
None provided as a basis for substantial equivalence.
Substantial Equivalence Conclusion:
The proposed Arcos One-piece Femoral Revision System has the same intended use and similar indications for use as the predicate devices. The proposed device has similar technological characteristics to the predicates, and the information provided herein demonstrates that:
- . any differences do not raise new questions of safety and effectiveness; and
- the proposed device is at least as safe and effective as the marketed predicate device.