(33 days)
No
The document describes a mechanical orthopedic implant system and its components. There is no mention of software, algorithms, or any technology that would typically incorporate AI or ML. The submission focuses on updating surgical techniques for pin selection.
Yes.
The device is a component of a segmental replacement system intended for the correction or revision of unsuccessful osteotomy, arthrodesis, previous joint replacement, revision of previously failed total joint arthroplasty, and tumor resections, which are all therapeutic interventions.
No
The device description clearly states its purpose is for "Segmental Femoral Replacement System" and "Compress Segmental Humeral Replacement System," functioning as a prosthetic implant to replace bone and tissue, not to diagnose a condition.
No
The device description clearly describes physical components (Anti-Rotation Spindles, anchor plug, femoral/humeral components, conical washers, pins) that are implanted in the body. This is a hardware medical device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended uses clearly describe surgical procedures involving the replacement or revision of bone segments due to various conditions (unsuccessful osteotomy, tumor resections, failed joint arthroplasty, trauma). These are all surgical interventions performed directly on the patient's body.
- Device Description: The device is described as components of a segmental femoral and humeral replacement system, designed to be implanted into the patient's bone to provide fixation and support. This is a surgically implanted device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (blood, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
In summary, the device is a surgically implanted prosthetic system, not a diagnostic tool used on in vitro samples.
N/A
Intended Use / Indications for Use
-
- Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
-
- Tumor resections.
-
- Revision of previously failed total joint arthroplasty.
-
- Trauma.
The Compress Segmental Femoral Replacement System components are intended for uncemented use.
- Trauma.
- Correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
- Tumor resections.
- Revision of previously failed total joint arthroplasty.
- Trauma.
The Compress Segmental Humeral Replacement System components are intended use.
The Discovery® Elbow and Nexel® Elbow components when used in conjunction with the Compress Segmental Humeral Replacement System are restricted to the Compress Segment System indications and are intended to be inserted with bone cement.
When components of the Compress Segmental Humeral Replacement System are used with Biomet's Discovery® Elbow System, the user should refer to the package insert contained with the Discovery® components for additional information (01-50-0901). Compatibility is limited to Biomet manufactured Discovery® Elbow components.
When components of the Compress Segmental Humeral Replacement System are used with the Zimmer Nexel® Elbow System, the user should refer to the package insert contained with the Nexel® components for additional information (87-6204-077-88).
When components of the Compress Segmental Humeral Replacement System are used with Biomet's Comprehensive® Segmental Revision System, the user should refer to the package insert contained with the Comprehensive Segmental Revision System components for additional information (01-50-0911).
The Modular Hybrid® Glenoid when used in conjunction with the Compress Segmental Humeral Replacement System is restricted to the Compress Segmental Humeral Replacement System indications and is intended to be used with bone cement. The optional porous titanium peg may be inserted without bone cement. The optional polyethylene peg should be inserted with bone cement.
Product codes
MBF, JDC, KWS, KWT, JDI, KRO, KWY, KWZ, LPH, LZO, MEH
Device Description
The Compress and Mini Compress Anti-Rotation Spindles are components of the Compress Segmental Femoral Replacement System and Compress Segmental Humeral Replacement System. The Anti-Rotation Spindles attach to an anchor plug and a proximal/distal femoral/humeral component to serve as a method of fixing a segmental joint replacement to a patient's host bone. The Anti-Rotation Spindles contain several conical washers which allow a compressive load to be applied at the prosthetic implant-bone interface at the time of device insertion. The Anti-Rotation Spindles also include a series of holes around the spindle collar to allow placement of pins to prevent rotation of the component. The purpose of this submission is the update of the surgical techniques associated with the Compress and Mini Compress Anti-Rotation Spindles to revise the recommended pin selection range for use with the Anti-Rotation Spindles.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Femoral, 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:
• Geometric evaluation was conducted, demonstrating the necessity for revisions to the subject surgical techniques to clarify the Anti-Rotation Pin usage.
Clinical Tests:
Clinical data was not provided for the subject devices.
The subject surgical technique modifications are implemented per the results of the geometric evaluation. The subject devices are substantially equivalent to the legally marketed predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3670 Shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits movement in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral component made of alloys such as cobalt-chromium-molybdenum (Co-Cr-Mo) and titanium-aluminum-vanadium (Ti-6Al-4V) alloys, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, or a combination of an articulating ultra-high molecular weight bearing surface fixed in a metal shell made of alloys such as Co-Cr-Mo and Ti-6Al-4V. The humeral component and glenoid backing have a porous coating made of, in the case of Co-Cr-Mo components, beads of the same alloy or commercially pure titanium powder, and in the case of Ti-6Al-4V components, beads or fibers of commercially pure titanium or Ti-6Al-4V alloy, or commercially pure titanium powder. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. This generic type of device is designed to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance: Shoulder Joint Metal/Polymer/Metal Nonconstrained or Semi-Constrained Porous-Coated Uncemented Prosthesis.”
0
January 22, 2019
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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Michael McBurney Regulatory Affairs Associate 56 East Bell Drive Warsaw, Indiana 46581
Re: K183553
Trade/Device Name: Compress and Mini Compress Anti-Rotation Spindles Regulation Number: 21 CFR 888.3670 Regulation Name: Shoulder Joint Metal/Polymer/Metal Nonconstrained Or Semi-Constrained Porous-Coated Uncemented Prosthesis Regulatory Class: Class II Product Code: MBF, JDC, KWS, KWT, JDI, KRO, KWY, KWZ, LPH, LZO, MEH Dated: December 18, 2018 Received: December 20, 2018
Dear Michael McBurney:
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 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
1
https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Daniel S. Ramsey -S 2019.01.22 17:35:50 -05'00'
FOR Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
K183553
Device Name
Compress Segmental Femoral Replacement System
Indications for Use (Describe)
-
- Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
-
- Tumor resections.
-
- Revision of previously failed total joint arthroplasty.
-
- Trauma.
The Compress Segmental Femoral Replacement System components are intended for uncemented use.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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."
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
K183553
Device Name
Compress Segmental Humeral Replacement System
Indications for Use (Describe)
-
Correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
-
Tumor resections.
-
Revision of previously failed total joint arthroplasty.
-
Trauma.
The Compress Segmental Humeral Replacement System components are intended use.
The Discovery® Elbow and Nexel® Elbow components when used in conjunction with the Compress Segmental Humeral Replacement System are restricted to the Compress Segment System indications and are intended to be inserted with bone cement.
When components of the Compress Segmental Humeral Replacement System are used with Biomet's Discovery® Elbow System, the user should refer to the package insert contained with the Discovery® components for additional information (01-50-0901). Compatibility is limited to Biomet manufactured Discovery® Elbow components.
When components of the Compress Segmental Humeral Replacement System are used with the Zimmer Nexel® Elbow System, the user should refer to the package insert contained with the Nexel® components for additional information (87-6204-077-88).
When components of the Compress Segmental Humeral Replacement System are used with Biomet's Comprehensive® Segmental Revision System, the user should refer to the package insert contained with the Comprehensive Segmental Revision System components for additional information (01-50-0911).
The Modular Hybrid® Glenoid when used in conjunction with the Compress Segmental Humeral Replacement System is restricted to the Compress Segmental Humeral Replacement System indications and is intended to be used with bone cement. The optional porous titanium peg may be inserted without bone cement. The optional polyethylene peg should be inserted with bone cement.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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
Image /page/4/Picture/0 description: The image shows the word "BIOMET" in a bold, sans-serif font. The letters are all capitalized and appear to be gray. A thin, dark line underlines the entire word, adding a sense of emphasis to the brand name.
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 subject 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on August 12, 2005.
| Sponsor: | Biomet Inc.
56 East Bell Drive
PO Box 587
Warsaw, IN 46581
Establishment Registration Number: 1825034 | |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Contact Person: | Michael McBurney
Regulatory Affairs Associate
Telephone: (574-373-2564) | |
| Date: | January 18, 2019 | |
| Subject Device: | Trade Name: Compress and Mini Compress Anti-
Rotation Spindles | |
| | Common Name: Limb salvage arthroplasty | |
| | Classification Name:
• MBF - prosthesis, shoulder, semi-constrained,
metal/polymer, uncemented (21 CFR 888.3670)
• JDC – prosthesis, elbow, constrained, cemented
(21 CFR 888.3150)
• KWS - prosthesis, shoulder, semi-constrained,
metal/polymer cemented (21 CFR 888.3660)
• KWT - prosthesis, shoulder, non-constrained,
metal/polymer cemented (21 CFR 888.3650)
• JDI - prosthesis, hip, semi-constrained,
metal/polymer, cemented (21 CFR 888.3350)
• KRO - prosthesis, knee, femorotibial, constrained
cemented, metal/polymer (21 CFR 888.3510)
• KWY - prosthesis, hip, hemi-, femoral,
metal/polymer, cemented or uncemented (21 CFR
888.3390)
• KWZ - prosthesis, hip, constrained, cemented or
uncemented, metal/polymer (21 CFR 888.3310) | |
5
- . LPH - prosthesis, hip, semi-constrained, metal/polymer, porous uncemented (21 CFR 888.3358) LZO - prosthesis, hip, semi-constrained, . metal/ceramic/polymer, cemented or non-porous, uncemented (21 CFR 888.3353) . MEH - prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate (21 CFR 888.3353) Predicate Device(s): Primary Predicate Device: K101475 Compress Anti-Rotation Spindles (Biomet, Inc.) Additional Predicates: K112905 Compress Segmental Humeral Replacement System (Biomet, Inc.) K123297 Compress Segmental Humeral Replacement System (Biomet, Inc.) Description: The Compress and Mini Compress Anti-Rotation Spindles are components of the Compress Segmental Femoral Replacement System and Compress Segmental Humeral Replacement System. The Anti-Rotation Spindles attach to an anchor plug and a proximal/distal femoral/humeral component to serve as a method of fixing a segmental joint replacement to a patient's host bone. The Anti-Rotation Spindles contain several conical washers which allow a compressive load to be applied at the prosthetic implant-bone interface at the time of device insertion. The Anti-Rotation Spindles also include a series of holes around the spindle collar to allow placement of pins to prevent rotation of the component. The purpose of this submission is the update of the surgical techniques associated with the Compress and Mini Compress Anti-Rotation Spindles to revise the recommended pin selection range for use with the Anti-Rotation Spindles. Summary of Technological Characteristics: The updates to the surgical techniques do not impact indications, materials, design features or dimensions, packaging or sterilization. The subject devices are
6
Traditional 510(k)
intended for use in limb salvage arthroplasty. The indications for use are as follows:
- . Indications for Use - Compress Segmental Femoral Replacement System:
- Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
-
- Tumor resections.
- Revision of previously failed total joint arthroplasty.
-
- Trauma.
The Compress Segmental Femoral Replacement System components are intended for uncemented use.
- Trauma.
Indications for Use - Compress Segmental ● Humeral Replacement System:
- Correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
-
- Tumor resections.
- Revision of previously failed total joint arthroplasty.
-
- Trauma.
The Compress Segmental Humeral Replacement System components are intended for uncemented use.
- Trauma.
The Discovery® Elbow and Nexel® Elbow components when used in conjunction with the Compress Segmental Humeral Replacement System are restricted to the Compress Segmental Humeral Replacement System indications and are intended to be inserted with bone cement.
When components of the Compress Segmental Humeral Replacement System are used with Biomet's Discovery® Elbow System, the user should refer to the package insert contained with the Discovery® components for additional information (01-50-0901). Compatibility is limited to Biomet manufactured Discovery® Elbow components.
When components of the Compress Segmental Humeral Replacement System are used with the Zimmer Nexel® Elbow System, the user should refer to the package insert contained with the Nexel®
7
components for additional information (87-6204-077-88).
When components of the Compress Segmental Humeral Replacement System are used with Biomet's Comprehensive® Segmental Revision System, the user should refer to the package insert contained with the Comprehensive® Segmental Revision System components for additional information (01-50-0911). The Modular Hybrid® Glenoid when used in conjunction with the Compress Segmental Humeral Replacement System is restricted to the Compress Segmental Humeral Replacement System indications and is intended to be used with bone cement. The optional porous titanium peg may be inserted without bone cement. The optional polyethylene peg should be inserted with bone cement.
Summary of Performance Data (Nonclinical and/or Clinical)
Non-Clinical Tests: .
- Geometric evaluation was conducted, o demonstrating the necessity for revisions to the subject surgical techniques to clarify the Anti-Rotation Pin usage.
● Clinical Tests:
Clinical data was not provided for the subject devices.
The subject surgical technique modifications are implemented per the results of the geometric evaluation. The subject devices are substantially equivalent to the legally marketed predicate devices.