(176 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and design of a femoral hip stem, with no mention of AI or ML.
Yes
The device is a femoral hip stem intended to treat various conditions like osteoarthritis, rheumatoid arthritis, and fractures, and it is designed to restore joint biomechanics and reduce pain, which are therapeutic functions.
No
The Sirius Femoral Hip Stem is a prosthetic implant designed to replace part of the hip joint. Its purpose is to treat conditions like osteoarthritis and fractures, as indicated in its "Intended Use / Indications for Use" section. It restores joint biomechanics and stability, which is a therapeutic function, not a diagnostic one. Diagnostic devices are used to identify or detect medical conditions, diseases, or abnormalities.
No
The device description clearly describes a physical implant (femoral hip stem) made of Co-Cr-Mo, along with physical accessories (centralizers made of PMMA). The performance studies focus on mechanical testing of the physical device. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The indications clearly describe the treatment of joint diseases and fractures, which are clinical conditions within the body. IVDs are used to examine specimens from the body (like blood, urine, tissue) to provide information about a patient's health.
- Device Description: The description details a physical implant (femoral hip stem) designed to be surgically placed within the body to restore joint function. This is a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on in vitro testing.
This device is a medical device used for surgical implantation, specifically a hip prosthesis.
N/A
Intended Use / Indications for Use
Components are intended for cemented use and may be used in partial and total hip arthroplasties.
Indications for Use:
- 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.
The Sirius Femoral Hip Stem is intended for cemented use only and may be used in partial and total hip arthroplasties.
Product codes (comma separated list FDA assigned to the subject device)
JDI, LZO, KWZ, MEH, LPH, KWY, JDG, LZY, OQG, OQH, OQI, PBI, KWL
Device Description
The Sirius femoral stem is a highly polished, double-tapered, cemented stem designed to reduce hip pain for patients and restore ioint biomechanics and stability. The short stem is designed to fit a broad range of patient anatomies for primary or revision cases. The features include a collarless, highly polished, doubletaper design, with a rectangular proximal geometry. The distal portion of the stem has a progressive diminishing cross-section. Each stem is packed with a winged and wingless centralizer, made of polymethylmethacrylate (PMMA), designed to help create a uniform mantle.. The size ranges are within the ranges of legally marketed predicates. The Sirius stem is made from Co-Cr-Mo, ASTM F799.
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)
Nonclinical performance testing was performed to support substantial equivalence. The testing included Distal and Proximal Stem fatigue testing of the worst-case stem, consistent with the "Guidance for Industry and FDA Staff Non-clinical Information for Femoral Stem Prostheses", ISO 7206-4:2010, ASTM F2068-09 and ISO 7206-6:1992, Cobalt Chrome Modular Head Pull-off from a Type 1 Reduced Taper, as outlined in ISO 7206-10:2003, as well as a Range of Motion analysis consistent with ISO 21535:2009 and a Comparison/ Justification for Modular Connections, Fretting and Corrosion Testing.
The results of non-clinical testing demonstrate that the device is as safe, as effective, and performs as well as or better than the predicate devices.
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.
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
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
Image /page/0/Picture/2 description: The image shows the logo for BIOMET MANUFACTURING CORP. The word "BIOMET" is in a stylized font with a geometric design. Below the logo, the words "MANUFACTURING CORP." are printed in a simple, sans-serif font. The text is black on a white background.
510(k) Summary
| Preparation Date: | March 6, 2013 | AUG 3 0 2013 |
|---|---|---|
| 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: | Sirius Femoral Stem | |
| Common Name: | Cemented modular hip prosthesis | |
| Classification Name: | JDI— Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented (21 CFR 888.3350). | |
| LZO—Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis (21 CFR 888.3353). | ||
| KWZ— Hip joint metal/polymer constrained cemented or uncemented prosthesis (21 CFR 888.3310). | ||
| MEH—Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis (21 CFR 888.3353). | ||
| LPH—Hip joint metal/polymer/metal semi-constrained porous-coated, uncemented prosthesis (21 CFR 888.3358). | ||
| KWY—Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis (21 CFR 888.3390). | ||
| JDG—Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis (21 CFR 888.3360). | ||
| LZY—Hip joint (hemi-hip) acetabular metal cemented prosthesis (21 CFR 888.3370). | ||
| OQG—Prosthesis, hip, semi-constrained, metal/polymer + additive, porous uncemented (888.3358) | ||
| 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 | ||
| Shipping Address: | 56 E. Bell Drive | |
| Warsaw, IN 46582 |
1
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)
KWL-Hip Joint Femoral (Hemi-Hip) Metallic Cemented or Uncemented Prosthesis (21 CFR 888.3360)
Legally Marketed Devices To Which Substantial Equivalence Is Claimed:
Generation 4 (Gen 4) Polished Femoral Hip System with Proximal Cement Spacer -Biomet-(K052639)
Collarless Polished Taper (CPT) Stem -Zimmer-(K960658)
Device Description:
The Sirius femoral stem is a highly polished, double-tapered, cemented stem designed to reduce hip pain for patients and restore ioint biomechanics and stability. The short stem is designed to fit a broad range of patient anatomies for primary or revision cases. The features include a collarless, highly polished, doubletaper design, with a rectangular proximal geometry. The distal portion of the stem has a progressive diminishing cross-section. Each stem is packed with a winged and wingless centralizer, made of polymethylmethacrylate (PMMA), designed to help create a uniform mantle.. The size ranges are within the ranges of legally marketed predicates. The Sirius stem is made from Co-Cr-Mo, ASTM F799.
Intended Use:
Components are intended for cemented use and may be used in partial and total hip arthroplasties.
Indications for Use:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 1.
- Rheumatoid arthritis. 2.
- Correction of functional deformity. 3.
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with 4. head involvement, unmanageable by other techniques.
- ട. Revision procedures where other treatment or devices have failed.
The Sirius Femoral Hip Stem is intended for cemented use only and may be used in partial and total hip arthroplasties.
Summary of Technologies:
The technological characteristics are the predicates identified in the Legally Marketed Devices to which substantial equivalence is claimed. The design is based on the taper-slip principle: the taper subsides at the stem/cement interface, and the double-taper becomes solidly engaged in the cement mantle. The geometry favors rotational stability to help minimize loosening. The stem is made of Co-Cr-Mo, ASTM F799, as are the predicates, and the centralizers are made of polymethylmethacrylate (PMMA). The Sirius stem is available in seven body sizes with numerous offsets to enable proper sizing and the Type 1 taper enables the choice of numerous modular heads. The Sirius stem features a short length, but the shortest stem in the Sirius system fits within the predicate range of sizes.
2
Non-Clinical Testing:
Nonclinical performance testing was performed to support substantial equivalence. The testing included Distal and Proximal Stem fatigue testing of the worst-case stem, consistent with the "Guidance for Industry and FDA Staff Non-clinical Information for Femoral Stem Prostheses", ISO 7206-4:2010, ASTM F2068-09 and ISO 7206-6:1992, Cobalt Chrome Modular Head Pull-off from a Type 1 Reduced Taper, as outlined in ISO 7206-10:2003, as well as a Range of Motion analysis consistent with ISO 21535:2009 and a Comparison/ Justification for Modular Connections, Fretting and Corrosion Testing.
Clinical Testing:
None provided as a basis for substantial equivalence.
The results of non-clinical testing demonstrate that the device is as safe, as effective, and performs as well as or better than the predicate devices.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized human figure embracing a circle. The words "HUMAN SERVICES-USA" are written around the top half of the circle, and "DEPARTMENT OF" are written around the bottom half of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 30, 2013
Ms. Becky Earl Regulatory Specialist Biomet Manufacturing Corporation P.O. Box 587 Warsaw, Indiana 46581
Re: K130610
Trade/Device Name: Sirius Femoral Hip Stem Regulation Number: 21 CFR 888.3350 Regulation Name: Hip joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JDI, LZO, KWZ, MEH, LPH, KWY, JDG, LZY, OQG, OQH, OQI, PBI, K WL Dated: May 31, 2013 Received: June 5, 2013
Dear Ms. Earl:
We have reviewed vour 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
4
Page 2 -- Ms. Becky Earl
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/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/ReportalProblem/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.
Erin I. Keith
For
Mark 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): K130610
Device Name: Sirius Femoral Hip Stem
Indications For Use:
-
- 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.
The Sirius Femoral Hip Stem is intended for cemented use only and may be used in partial and total hip arthroplasties.
Prescription Use_ × (Part 21 CFR 801 Subpart D) Over-The-Counter Use _ NO (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elizabeth L. Frank -S
Page 1 of 1
Division of Orthopedic Devices