Sirius Femoral Stem, Size 30A
Device Facts
| Record ID | K142295 |
|---|---|
| Device Name | Sirius Femoral Stem, Size 30A |
| Applicant | Biomet, Inc. |
| Product Code | JDI · Orthopedic |
| Decision Date | Sep 15, 2014 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 888.3350 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Correction of functional deformity. 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. 5. 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.
Device Story
Sirius Femoral Hip Stem is a cemented, modular hip prosthesis designed to reduce pain and restore joint biomechanics. Device features a highly polished, double-tapered, collarless design with rectangular proximal geometry and a progressive diminishing distal cross-section. Used by orthopedic surgeons in clinical settings for primary or revision hip arthroplasties. The stem is implanted into the femur using bone cement to provide stability and structural support for the hip joint. By replacing the damaged femoral head and neck, the device aims to restore patient mobility and function.
Clinical Evidence
Bench testing only. Performance data includes proximal fatigue testing (ISO 7206-6), distal fatigue testing (ISO 7206-4), and range of motion testing (ISO 21535). No clinical data presented.
Technological Characteristics
Material: CoCrMo per ASTM F799. Design: Highly polished, double-tapered, collarless, rectangular proximal geometry, progressive diminishing distal cross-section. Energy source: N/A (mechanical). Connectivity: N/A. Sterilization: Sterile, single-use.
Indications for Use
Indicated for patients with non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity, or proximal femur fractures (non-union, femoral neck, trochanteric) requiring partial or total hip arthroplasty, including revision procedures.
Regulatory Classification
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).
Predicate Devices
- Sirius Femoral Stem (K130610)
Submission Summary (Full Text)
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 15, 2014
Biomet, Inc. Mr. Jason Dugger Regulatory Affairs Specialist 56 East Bell Drive Warsaw, Indiana 46581
Re: K142295 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, KWL Dated: August 14, 2014 Received: August 18, 2014
Dear Mr. Dugger:
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
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Page 2 - Mr. Jason Dugger
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" (21 CFR 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
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BIOMET
## INDICATIONS FOR USE STATEMENT
510(k) Number (if known): ------- K142295
Sirius Femoral Hip Stem Device Name:
#### INDICATIONS FOR USE:
- 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- 2. Rheumatoid arthritis.
- 3. Correction of functional deformity.
- 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
- 5. 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)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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510(k) Summary Sirius Femoral Stem| Special 510(k)
# 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 Sirius Femoral Stem Size 30A Special 510(k) premarket notification.
| Sponsor: | Biomet Inc.<br>56 East Bell Drive<br>PO Box 587<br>Warsaw, IN 46581<br>Establishment Registration Number: 1825034 |
|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Jason Dugger<br>Regulatory Affairs Specialist |
| Date: | September 12, 2014 |
| Subject Device: | Trade Name: Sirius Femoral Hip Stem<br>Common Name: Cemented Modular Hip Prosthesis<br>Classification Name:<br>• JDI- Prosthesis, Hip, Semi-Constrained, metal/Polymer, Cemented<br>(21 CFR 888.3350)<br>• LZO- Hip joint metal/ ceramic/ polymer semi-constrained<br>cemented or nonporous uncemented prostheses (21 CFR<br>888.3353)<br>• KWZ- Hip joint metal/ polymer constrained cemented or<br>uncemented prosthesis (21 CFR 888.3310)<br>• MEH- Hip joint metal/ceramic/ polymer semi-constrained<br>cemented or nonporous uncemented prosthesis (21 CFR<br>888.3353)<br>• LPH- Hip joint metal/ polymer/ metal semi-constrained porous-<br>coated, uncemented prosthesis (21 CFR 888.3390)<br>• KWY- Hip joint femoral (hemi-hip) metal/ polymer cemented or<br>uncemented prosthesis (21 CFR 888.3390)<br>• JDG- Hip joint femoral (hemi-hip) metallic cemented or<br>uncemented prosthesis (21 CFR 888.3360)<br>• LZY- Hip joint (hemi-hip) acetabular metal cemented prosthesis<br>(21 CFR 888.3370)<br>• OQG- Prosthesis, hip, semi-constrained, metal/polymer + additive,<br>porous uncemented (21 CFR 888.3358)<br>• OQH- Hip, semi-constrained, cemented, metal/ polymer + additive<br>cemented (21 CFR 888.3350)<br>• OQI- Hip, semi-constrained, cemented, metal/ ceramic/ polymer +<br>additive, porous uncemented (21 CFR 888.3353)<br>• PBI- Prosthesis, hip, constrained, cemented or uncemented,<br>metal/ polymer, + additive (21 CFR 888.3310) |
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- · KWL- Hip Joint Femoral (Hemi-Hip) Metallic Cemented or Uncemented Prosthesis (21 CFR 888.3360)
## Legally marketed devices to which substantial equivalence is claimed:
- K130610 – Sirius Femoral Stem – Biomet, Inc.
#### Device Description
The Sirius Femoral Stem is a highly polished, double-tapered, cemented stem designed to reduce hip pain for patients and restore joint biomechanics and stability. The femoral stem is designed to fit patient femoral anatomies for primary or revision hip arthroplasties.
The proposed device is made from CoCrMo per ASTM F799.The features include a collarless, highly polished, double taper design with a rectangular proximal geometry. The distal portion of the stem has a progressive diminishing cross-section.
#### Intended Use and Indications for Use
- 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- Rheumatoid arthritis. 2.
- 3. Correction of functional deformity.
- 4. 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. 5.
The Sirius Femoral Hip Stem is intended for cemented use only and may be used in partial and total hip arthroplasties.
#### Summary of Technological Characteristics
The rationale for substantial equivalence is based on consideration of the following characteristics:
- Intended Use: The proposed and predicate Sirius Femoral Stem devices have the identical intended use.
- Indications for Use: The proposed and predicate Sirius Femoral Stem devices have identical indications for use.
- Materials: The proposed and predicate Sirius Femoral Stem devices are manufactured from CoCrMo per ASTM F799.
- Design Features: The proposed and predicate Sirius Femoral Stem devices incorporate the same design features.
- Sterilization: The proposed and predicate Sirius Femoral Stem devices are provided sterile via the same sterilization methods for single-use.
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BIOMET
## Summary of Performance Data
Results from mechanical tests demonstrate that the proposed Sirius Femoral Stem is substantially equivalent to the predicate femoral stems. A description of the tests performed on the proposed device is as follows:
- Proximal Fatigue Testing - ISO 7206-6
- Distal Fatigue Testing - ISO 7206-4
- Range of Motion ISO 21535 ●
#### Substantial Equivalence Conclusion
The proposed Sirius Femoral Stem has the same intended use and indications for use as the predicate devices. Performance test data demonstrates the device is as safe and effective and is substantially equivalent to the legally marketed predicate devices.
