LogoFDA 510(k) Search
K Number
K142295
Device Name
Sirius Femoral Stem, Size 30A
Manufacturer
Biomet, Inc.
Date Cleared
2014-09-15

(28 days)

Product Code
JDIJDGKWLKWYKWZLPHLZOLZYMEHOQGOQHOQIPBI
Regulation Number
888.3350
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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 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.
More Information

K130610

None

No
The summary describes a mechanical implant (femoral hip stem) and its intended use and performance testing, with no mention of AI or ML technology.

Yes
The device is intended to treat multiple conditions, including degenerative joint disease, rheumatoid arthritis, non-union fractures, and to restore joint biomechanics and stability, which are therapeutic actions.

No
The device, a femoral hip stem, is intended for treatment (e.g., hip arthroplasties) and not for diagnosing conditions. Its purpose is to restore joint biomechanics and reduce pain, which are therapeutic functions.

No

The device description clearly describes a physical implantable device made of CoCrMo, not software.

Based on the provided information, 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 provide information about a person's health.
  • Device Description and Intended Use: The description clearly states that the Sirius Femoral Hip Stem is a surgical implant used in hip replacement procedures. Its purpose is to replace a damaged or diseased part of the femur (thigh bone) and restore joint function.
  • Lack of Diagnostic Activity: There is no mention of the device being used to analyze samples or provide diagnostic information. Its function is purely mechanical and structural within the body.

Therefore, the Sirius Femoral Hip Stem falls under the category of a surgical implant, not an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

    1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
    1. Rheumatoid arthritis.
    1. Correction of functional deformity.
    1. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
    1. 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

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 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Hip (Femoral)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Prescription Use (Part 21 CFR 801 Subpart D)

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

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

Key Metrics

Not Found

Predicate Device(s)

K130610

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, overlapping to create a sense of depth and connection. The profiles are rendered in a simple, line-art style.

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

1

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

2

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.
    1. Rheumatoid arthritis.
    1. Correction of functional deformity.
    1. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
    1. 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)

3

Image /page/3/Picture/1 description: The image shows the word "BIOMET" in all caps. The letters are a dark gray color and are evenly spaced. The font is sans-serif and appears to be bolded.

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.
56 East Bell Drive
PO Box 587
Warsaw, IN 46581
Establishment Registration Number: 1825034 |
|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Jason Dugger
Regulatory Affairs Specialist |
| Date: | September 12, 2014 |
| Subject Device: | Trade Name: Sirius Femoral Hip 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 prostheses (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 888.3390)
• 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 (21 CFR 888.3358)
• OQH- Hip, semi-constrained, cemented, metal/ polymer + additive
cemented (21 CFR 888.3350)
• OQI- 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) |

4

Image /page/4/Picture/1 description: The image shows the word "BIOMET" in a simple, sans-serif font. The letters are all capitalized and appear to be a dark gray or black color. The word is presented against a white background, creating a clean and minimalist look. The font is uniform in thickness, giving the word a solid and stable appearance.

  • · 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.
    1. Correction of functional deformity.
    1. 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.

5

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.