(111 days)
Not Found
No
The 510(k) summary describes a mechanical orthopedic implant (humeral stem) and does not mention any software, algorithms, or AI/ML capabilities. The performance studies are mechanical fatigue tests, not related to AI/ML performance.
Yes
The device is a fracture stem used for the surgical repair and treatment of various conditions affecting the shoulder joint, including fractures, degenerative joint diseases, and revision surgeries. This aligns with the definition of a therapeutic device which is intended to treat or alleviate a disease or condition.
No
The device is a surgical implant (humeral stem) used for joint replacement, not for diagnosing medical conditions.
No
The device description clearly describes a physical implant (humeral stem) made of cast Co-Cr-Mo with a porous plasma-spray coating and fins. This is a hardware device, 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 tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that this device is a "Porous Coated Comprehensive® Fracture Stem," which is a humeral stem made of cast Co-Cr-Mo. This is an implantable medical device used in surgery.
- Intended Use: The intended uses listed are all related to surgical procedures for treating conditions affecting the shoulder joint, such as osteoarthritis, rheumatoid arthritis, fractures, and deformities. These are clinical applications, not laboratory tests on bodily samples.
Therefore, this device falls under the category of a surgical implant or prosthesis, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Porous Coated Comprehensive® Fracture Stems are indicated for:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- Rheumatoid arthritis.
- Revision where other devices or treatments have failed.
- Correction of functional deformity.
- Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
- Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate.
Humeral/glenoid components with a porous coated surface coating are indicated for either cemented or uncemented biological fixation applications. (Metal backed glenoid components offer optional screw fixation.)
Glenoid components with Hydroxyapatite (HA) coating applied over the porous coating are indicated only for uncemented biological fixation applications. (Metal backed glenoid components offer optional screw fixation).
The Comprehensive® Fracture Stems are intended for use with the Bio-Modular Humeral Heads and glenoid components and Versa-Dial Humeral Heads.
The Comprehensive™ Humeral Positioning Sleeves are for cemented use only and are intended for use with the Comprehensive™ Fracture Stem.
The Comprehensive™ Shoulder Stems (Fracture, Primary and Revision) are intended for use with the Bio-Modular™ Humeral Heads and glenoid components and Versa-Dial™ Humeral Heads.
The Versa-Dial™ Humeral Head Prosthesis is intended for use only with the Comprehensive™ Shoulder Stems (Fracture, Primary and Revision), the Bio-Modular™ Shoulder Stems, the glenoid components of the Bio-Modular Shoulder System, and the glenoid components of the Comprehensive™ Shoulder System.
When a humeral stem and/or Versa-Dial™ Taper Adapter is being used for a reverse shoulder application, the user should refer to the package insert (01-50-0903) continued with the reverse shoulder components for additional information, including alternate indications.
Product codes (comma separated list FDA assigned to the subject device)
PHX, KWT, KWS, MBF, HSD
Device Description
Biomet's Porous Coated Comprehensive® Fracture Stems consist of a humeral stem comprised of cast Co-Cr-Mo. The Proximal body of the stem contains 4 fins, three of which include suture holes to facilitate multiple attachment sites for the bone. The proximal body also contains a porous plasma-spray coating, which will allow for optimum fixation of the stem in the proximal humerus. The humeral stem contains a reverse taper which allows for the use of either a Bio-Modular® humeral head or glenoid component, a Versa-Dial® humeral head, or the Comprehensive® Reverse Shoulder humeral components.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Proximal humerus, Shoulder joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Median Fatigue Test
No clinical data was necessary for a determination of substantial equivalence. The results of testing indicated the devices did not raise any new safety and efficacy issues and were found to be substantially equivalent to 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.
Comprehensive Humeral Fracture Stems (K023063), Comprehensive Primary Shoulder Stems (K060692), Kirschner® Neer-III™ Modular Proximal Humerus (K874643)
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
§ 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder 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 humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid 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. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” and
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,”
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-aluminum 4-vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-chromium-molybdenum casting alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-chromium-molybdenum alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” and
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(v) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal,”
(vii) F 1378-97 “Standard Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”
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 eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 2, 2016
Biomet Manufacturing Corporation Mr. Brian Kincaid Global Project Manager, Regulatory Affairs - SET 56 East Bell Drive Warsaw. Indiana 46582
Re: K140652
Trade/Device Name: Porous Coated Comprehensive® Fracture Stems Regulation Number: 21 CFR 888.3650 Regulation Name: Shoulder joint metal/polymer non-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX, KWT, KWS, MBF, HSD Dated: April 4, 2014 Received: April 8, 2014
Dear Mr. Kincaid:
This letter corrects our substantially equivalent letter of July 3, 2014.
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
1
Page 2 - Mr. Brian Kincaid
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 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. 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/Resourcesfor You/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
Indications for Use
510(k) Number (if known) K140652
Device Name Porous Coated Comprehensive® Fracture Stems
Indications for Use (Describe)
The Porous Coated Comprehensive® Fracture Stems are indicated for:
-
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
-
- Rheumatoid arthritis.
-
- Revision where other devices or treatments have failed.
-
- Correction offunctional deformity.
-
Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
-
Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate.
Humeral/glenoid components with a porous coated surface coating are indicated for either cemented biological fixation applications. (Metal backed glenoid components offer optional screw fixation.) Glenoid components with Hydroxyapatite (HA) coating applied over the porous coating are indicated only for uncemented biological fixation applications. (Metal backed glenoid components offer optional screw fixation).
The Comprehensive® Fracture Stems are intended for use with the Bio-Modular Humeral Heads and glenoid components and Versa-Dial Humeral Heads.
The Comprehensive™ Humeral Positioning Sleeves are for cemented use only and are intended for use with the Comprehensive™ Fracture Stem.
The Comprehensive™ Shoulder Stems (Fracture, Primary and Revision) are intended for use with the Bio-ModularTM Humeral Heads and glenoid components and Versa-DialTM Humeral Heads.
The Versa-Dial™ Humeral Head Prosthesis is intended for use only with the ComprehensiveTM Shoulder Stems (Fracture, Primary and Revision), the Bio-Modular™ Shoulder Stems, the glenoid components of the Bio-ModularTM Shoulder System, and the glenoid components of the Comprehensive™ Shoulder System.
When a humeral stem and/or Versa-DialTM Taper Adapter is being used for a reverse shoulder application, the user should refer to the package insert (01-50-0903) continued with the reverse shoulder components for additional information, including alternate indications.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
O Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
3
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."
4
JUL 0 3 2014
Section 5 - 510(k) Summary
A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92
| Submitter Information | ||
|---|---|---|
| Name | Biomet Manufacturing Corp. | |
| Address | 56 East Bell Drive | |
| Warsaw, IN 46582 | ||
| Phone number | (574) 267-6639 | |
| Fax number | (574) 372-1718 | |
| Establishment | ||
| Registration Number | 1825034 | |
| Name of contact | ||
| person | Brian Kincaid | |
| -Date prepared | March 7, 2014 | |
| Name of device | ||
| Trade or proprietary name | Porous Coated Comprehensive® Fracture Stems | |
| Common or usual name | Shoulder Replacement Prosthesis | |
| Classification name | Regulation | Product Code |
| Shoulder joint | ||
| metal/polymer non- | ||
| constrained cemented | ||
| prosthesis | 21 CFR 888.3650 | KWT |
| Shoulder joint, | ||
| metal/polymer, semi- | ||
| constrained, cemented | ||
| prosthesis | 21 CRF 888.3660 | KWS |
| Shoulder joint - | ||
| metal/polymer/metal non- | ||
| constrained or semi- | ||
| constrained porous-coated | ||
| uncemented prosthesis | 21 CFR 888.3670 | MBF |
| Shoulder joint humeral | ||
| (hemi-shoulder) metallic | ||
| uncemented prosthesis | 21 CFR 888.3690 | HSD |
| Classification panel | Orthopedics | |
| Legally marketed device(s) to | ||
| which equivalence is claimed | Comprehensive Humeral Fracture Stems (K023063) | |
| Comprehensive Primary Shoulder Stems (K060692) | ||
| Kirschner® Neer-III™ Modular Proximal Humerus | ||
| (K874643) | ||
| Reason for 510(k) submission | Line extension | |
| Device description | Biomet's Porous Coated Comprehensive® Fracture Stems | |
| consist of a humeral stem comprised of cast Co-Cr-Mo. | ||
| The Proximal body of the stem contains 4 fins, three of | ||
| which include suture holes to facilitate multiple | ||
| attachment sites for the bone. The proximal body also | ||
| contains a porous plasma-spray coating, which will allow |
Porous Coated Comprehensive® Fracture Stems Traditional 510(k) Biomet Manufacturing Corp.
5
K140652 (page 2/3)
.
. ・ ·
l .
・
·
| for optimum fixation of the stem in the proximal humerus. The humeral stem contains a reverse taper which allows for the use of either a Bio-Modular® humeral head or glenoid component, a Versa-Dial® humeral head, or the Comprehensive® Reverse Shoulder humeral components. | |
|---|---|
| Indications for use | The Porous Coated Comprehensive® Fracture Stems are indicated for: |
| 1) Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. | |
| 2) Rheumatoid arthritis. | |
| 3) Revision where other devices or treatments have failed. | |
| 4) Correction of functional deformity. | |
| 5) Fractures of the proximal humerus, where other methods of treatment are deemed inadequate. | |
| 6) Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate. | |
| Humeral/glenoid components with a porous coated surface coating are indicated for either cemented or uncemented biological fixation applications. (Metal backed glenoid components offer optional screw fixation.) | |
| Glenoid components with Hydroxyapatite (HA) coating applied over the porous coating are indicated only for uncemented biological fixation applications. (Metal backed glenoid components offer optional screw fixation). | |
| The Comprehensive® Fracture Stems are intended for use with the Bio-Modular Humeral Heads and glenoid components and Versa-Dial Humeral Heads. | |
| The Comprehensive™ Humeral Positioning Sleeves are for cemented use only and are intended for use with the Comprehensive™ Fracture Stem. | |
| The Comprehensive™ Shoulder Stems (Fracture, Primary and Revision) are intended for use with the Bio-Modular™ Humeral Heads and glenoid components and Versa-Dial™ |
Porous Coated Comprehensive® Fracture Stems Traditional 510(k)
Biomet Manufacturing Corp.
.
·
ﻟﺴﺮ
6
K140652 (page 3/3)
)
| Humeral Heads. | |
|---|---|
| The Versa-Dial™ Humeral Head Prosthesis is intended for use only with the Comprehensive™ Shoulder Stems (Fracture, Primary and Revision), the Bio-Modular™ Shoulder Stems, the glenoid components of the Bio- Modular Shoulder System, and the glenoid components of the Comprehensive™ Shoulder System. | |
| When a humeral stem and/or Versa-Dial™ Taper Adapter is being used for a reverse shoulder application, the user | |
| should refer to the package insert (01-50-0903) | |
| continued with the reverse shoulder components for | |
| additional information, including alternate indications. |
Summary of The Technological Characteristics Compared to the Predicate
The new device is identical or similar in design, materials, and intended use as the
predicate devices. Design differences have been demonstrated to not affect safety or
effectiveness or raise new issues of safety or effectiveness.
PERFORMANCE DATA
SUMMARY OF NON-CLINICAL TESTS
Median Fatigue Test
SUMMARY OF CLINICAL-TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL
EQUIVALENCE AND/OR OF CLINICAL INFORMATION
No clinical data submitted
CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA
No clinical data was necessary for a determination of substantial equivalence. The results of
testing indicated the devices did not raise any new safety and efficacy issues and were found
to be substantially equivalent to the predicate devices.
・
.
.
⎞
•
.