(128 days)
No
The 510(k) summary describes a mechanical implant and positioning sleeves for shoulder surgery. There is no mention of AI, ML, image processing, or any software component that would suggest the use of these technologies. The performance studies focus on sterilization and biocompatibility, not algorithmic performance.
Yes.
The device is used in conjunction with the Comprehensive Humeral Fracture System for conditions like non-inflammatory degenerative joint disease, rheumatoid arthritis, and fractures of the proximal humerus, indicating a therapeutic purpose.
No
The device is described as a surgical implant (humeral components, glenoid components, humeral heads) and positioning sleeves used during surgery for conditions like degenerative joint disease, rheumatoid arthritis, fractures, and functional deformity. These are treatment devices, not diagnostic ones.
No
The device description explicitly states the device is composed of Polymethylmethacrylate (PMMA) and is a physical sleeve used with a humeral fracture stem, indicating it is a hardware device.
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 and intended use clearly indicate that this device is a surgical implant (a humeral fracture positioning sleeve) used during surgery to aid in the placement of a humeral stem. It is a physical component used in a surgical procedure, not a tool for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing samples, performing tests, or providing diagnostic information based on biological markers.
Therefore, this device falls under the category of a surgical implant or instrument, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
INDICATIONS
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- Rheumatoid arthritis.
- 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.
Optional use in revision: in some medical conditions (e.g. revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure.
Humeral components with a MacroBond® Surface Coating are indicated for either cemented or uncemented press-fit applications.
Humeral components with a porous coated surface coating are indicated for either cemented biological fixation applications.
The Comprehensive® Modular Hybrid® Glenoid is intended to be implanted with bone cement. The optional porous titanium peg may be inserted without bone cement. The optional polyethylene peg should be inserted with bone cement. The Comprehensive Humeral Positioning Sleeves are for cemented use only and are intended for use with the Comprehensive Fracture Stem.
The Versa-Dial Humeral Head Prosthesis is intended for use only with the Comprehensive Shoulder Stems (Fracture, Primary and Revision), and the glenoid components of the Comprehensive Shoulder System.
The Titanium Versa-Dial Humeral Head Prosthesis is indicated for patients with suspected cobalt alloy sensitivity. The wear properties of Titanium and Titanium alloys are inferior to that of cobalt alloy. A Titanium humeral head is not recommended for patients who lack suspected material sensitivity to cobalt alloy.
Product codes (comma separated list FDA assigned to the subject device)
KWS, KWT
Device Description
The Comprehensive Humeral Fracture Positioning Sleeves is composed of Polymethylmethacrylate (PMMA) and is used in conjunction with the Comprehensive Humeral Fracture System. The device is a sleeve that fits over the distal tapered end of the Comprehensive Humeral Fracture Stem and stops at a point below the fins of the stem.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Humeral
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: .
Testing was completed to demonstrate that the change in bioburden reduction process using REVOX technology does not have any impact on sterilization, shelf life, or biocompatibility of the device.
Clinical Tests:
None provided
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
§ 888.3660 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
December 10, 2021
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Biomet Inc. % Aishwarya Pandey Regulatory Affairs Specialist Biomet INC 56 East Bell Drive Warsaw, Indiana 46581
Re: K212435
Trade/Device Name: Comprehensive Humeral Fracture Positioning Sleeves Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWS, KWT Dated: November 8, 2021 Received: November 12, 2021
Dear Aishwarya Pandey:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Jiping Chen, Ph.D., M.P.H. Acting Division Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212435
Device Name
Comprehensive Humeral Fracture Positioning Sleeve
Indications for Use (Describe) INDICATIONS
-
Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
-
Rheumatoid arthritis.
-
- 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.
Optional use in revision: in some medical conditions (e.g. revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure.
Humeral components with a MacroBond® Surface Coating are indicated for either cemented or uncemented press-fit applications.
Humeral components with a porous coated surface coating are indicated for either cemented biological fixation applications.
The Comprehensive® Modular Hybrid® Glenoid is intended to be implanted with bone cement. The optional porous titanium peg may be inserted without bone cement. The optional polyethylene peg should be inserted with bone cement. The Comprehensive Humeral Positioning Sleeves are for cemented use only and are intended for use with the Comprehensive Fracture Stem.
The Versa-Dial Humeral Head Prosthesis is intended for use only with the Comprehensive Shoulder Stems (Fracture, Primary and Revision), and the glenoid components of the Comprehensive Shoulder System.
The Titanium Versa-Dial Humeral Head Prosthesis is indicated for patients with suspected cobalt alloy sensitivity. The wear properties of Titanium and Titanium alloys are inferior to that of cobalt alloy. A Titanium humeral head is not recommended for patients who lack suspected material sensitivity to cobalt alloy.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
| Sponsor: | Biomet Inc.
56 East Bell Drive
PO Box 587
Warsaw, IN 46581
Establishment Registration Number: 1825034 | | |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|--------------|
| Contact Person: | Aishwarya Pandey
Regulatory Affairs Specialist
Telephone: +1 574 373 3740
Fax: (574-372-1683) | | |
| Date: | 02-August-2021 | | |
| Subject Device: | Trade Name: Comprehensive Humeral Fracture
Positioning Sleeves
Common Name: Centering sleeve
Classification Name:
KWS: Shoulder joint metal/polymer semi-
constrained cemented prosthesis (21 CFR
888.3660) KWT: Shoulder joint metal/polymer non-
constrained cemented prosthesis.
(21CFR888.3650) | | |
| Predicate Device(s): | K193038 | Comprehensive
Shoulder System | Biomet, INC. |
| | K033506 | Comprehensive
Humeral Fracture
Positioning
Sleeves | Biomet, INC. |
| Reference Device(s): | K193546 | Distal Centralizer | Biomet, INC. |
| Device Description: | The Comprehensive Humeral Fracture Positioning Sleeves is composed of
Polymethylmethacrylate (PMMA) and is used in conjunction with the | | |
Comprehensive Humeral Fracture System. The device is a sleeve that fits over the distal tapered end of the Comprehensive Humeral Fracture Stem and stops at a point below the fins of the stem.
4
The purpose of this submission is to move the Comprehensive Humeral Fracture Positioning Sleeve devices from Branson bioburden reduction process into a bioburden reduction process using REVOX technology.
Indications for Use:
-
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
-
- Rheumatoid arthritis.
-
- 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.
Optional use in revision: in some medical conditions (e.g. revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure.
Humeral components with a MacroBond® Surface Coating are indicated for either cemented or uncemented press-fit applications.
Humeral components with a porous coated surface coating are indicated for either cemented or uncemented biological fixation applications.
The Comprehensive® Modular Hybrid® Glenoid is intended to be implanted with bone cement. The optional porous titanium peg may be inserted without bone cement. The optional polyethylene peg should be inserted with bone cement.
The Comprehensive Humeral Positioning Sleeves are for cemented use only and are intended for use with the Comprehensive Fracture Stem.
The Versa-Dial Humeral Head Prosthesis is intended for use only with the Comprehensive Shoulder Stems (Fracture, Primary and Revision), and the glenoid components of the Comprehensive Shoulder System.
The Titanium Versa-Dial Humeral Head Prosthesis is indicated for patients with suspected cobalt alloy sensitivity. The wear properties of Titanium and Titanium alloys are inferior to that of cobalt alloy. A Titanium humeral head is not recommended for patients who lack suspected material sensitivity to cobalt alloy.
Summary of Technological Characteristics:
The rationale for substantial equivalence is based on consideration of the following characteristics:
- Intended Use: Identical to predicate
- Indications for Use: Identical to predicate ●
- Materials: Identical to predicate ●
- Design Features: Identical to predicate ●
- Sterilization: Identical to predicate .
5
Summary of Performance Data (Nonclinical and/or Clinical)
Non-Clinical Tests: .
Testing was completed to demonstrate that the change in bioburden reduction process using REVOX technology does not have any impact on sterilization, shelf life, or biocompatibility of the device.
Clinical Tests:
None provided
Substantial Equivalence
Conclusion
Based on the information contained within this submission, it is concluded that the Comprehensive Humeral Positioning Sleeves is substantially equivalent to the identified predicate and reference devices.