(29 days)
Not Found
No
The device description and intended use focus on a mechanical implant for bone replacement, with no mention of AI/ML capabilities or data processing.
No
The device is a metallic segmental fixation system intended to replace resected parts of the humerus, primarily used for structural replacement of bone rather than for active therapeutic treatment of a disease or condition.
No
The device is described as a "metallic segmental fixation system intended to replace the resected part of the humerus" and is indicated for conditions like correction of unsuccessful procedures, tumor resections, or trauma. This indicates it is a therapeutic or reconstructive device, not one used for diagnosis.
No
The device description clearly states it is a "metallic segmental fixation system" and describes physical components like a "spring system built into the stem," indicating it is a hardware device, not software-only.
Based on the provided text, the 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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The Compress® Segmental Humeral Replacement System is described as a "metallic segmental fixation system intended to replace the resected part of the humerus in cases of severe bone loss." This is a surgical implant, not a device used for testing biological samples.
- Intended Use: The intended uses listed (correction/revision of unsuccessful procedures, tumor resections, revision of failed arthroplasty, trauma) all involve surgical intervention and replacement of bone, not diagnostic testing.
Therefore, the device falls under the category of a surgical implant or prosthetic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Compress® Segmental Humeral Replacement System is indicated for:
- 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.
Product codes
MBF
Device Description
The Compress® Segmental Humeral Replacement System is a metallic segmental fixation system intended to replace the resected part of the humerus in cases of severe bone loss. The Compress® Segmental Humeral Replacement System components are intended for uncemented use. The design of the Compress® System allows a compressive load to be applied at the prosthetic implant-bone interface at the time of device insertion. This is accomplished through a spring system built into the stem.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
humerus
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)
No non-clinical data was submitted
No clinical data submitted
No clinical or non-clinical data was necessary for a determination of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
Image /page/0/Picture/1 description: The image shows the logo for BIOMET MANUFACTURING CORP. The word "BIOMET" is in a stylized font with the letters connected. Below the logo is the text "MANUFACTURING CORP." in a simple, sans-serif font. The text is left-aligned and in all caps.
NOV 2 0 2012
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) 371-1027 |
| Establishment Registration Number | 1825034 |
| Name of contact person | Patricia Sandborn Beres |
| Senior Regulatory Specialist | |
| Biomet Manufacturing Corp. | |
| Date prepared | October 16, 2012 |
| NAME OF DEVICE | |
| Trade or proprietary name | Compress® Segmental Humeral Replacement System |
| Common or usual name | Humeral stem prosthesis |
| Classification name | Shoulder joint/metal/polymer/metal non-constrained or semi- |
| constrained porous-coated uncemented prosthesis | |
| Classification panel | Orthopedics |
| Regulation | 21 CFR 888.3670 |
| Product Code(s) | MBF |
| Legally marketed device(s) to which equivalence is claimed | Compress® Segmental Humeral Replacement System |
| K112905 | |
| Reason for 510(k) submission | Add compatibility to the Comprehensive® Segmental Revision |
| System (SRS), 510(k) 111746. | |
| Device description | The Compress® Segmental Humeral Replacement System is a |
| metallic segmental fixation system intended to replace the | |
| resected part of the humerus in cases of severe bone loss. The | |
| Compress® Segmental Humeral Replacement System | |
| components are intended for uncemented use. The design of | |
| the Compress® System allows a compressive load to be applied | |
| at the prosthetic implant-bone interface at the time of device | |
| insertion. This is accomplished through a spring system built | |
| into the stem. | |
| Intended use of the device | Replacement of the resected part of the humerus |
Mailing Address:
P.O. Box 587
Warsaw, IN 46581-0587
Tota Free, 800,348,9500 Office: 574 267.8639 Main Fax. 574 267 8137 www.blomet.com
Shipping Address:
56 East Bell Doive
Warsaw, IN 46582
f 2
1
1
.
| Indications for use | The Compress® Segmental Humeral Replacement System is indicated for:
- 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. |
|-----------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| PERFORMANCE DATA | |
| Summary Of Non-Clinical Tests Conducted For Determination Of Substantial Equivalence | |
| No non-clinical data was submitted | |
| 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 or non-clinical data was necessary for a determination of substantial equivalence. | |
.
·
2 of 2
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circular pattern around the symbol. The logo is black and white and appears to be a scanned image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
November 20, 2012
Biomet Manufacturing Corporation % Ms. Patricia Sandborn Beres Senior Regulatory Specialist P.O. Box 587 Warsaw, Indiana 465801
Re: K123297
Trade/Device Name: Compress Segmental Humeral Replacement System Regulation Number: 21 CFR 888.3670 Regulation Name: Shoulder joint metal/polymer/metal non-constrained or semi-constrained porous-coated uncemented prosthesis Regulatory Class: II Product Code: MBF Dated: October 24, 2012
Received: October 25, 2012
Dear Ms. Beres:
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. Ilsting 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
3
Page 2 - Ms. Patricia Sandborn Beres
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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,
Erin I Keith
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K123297
Device Name: Compress® Segmental Humeral Replacement System
Indications for Use:
The Compress® Segmental Humeral Replacement System is indicated for:
- Correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. 1.
- Tumor resections. 2.
-
- Revision of previously failed total joint arthroplasty.
- Trauma. 4.
The Compress® Segmental Humeral Replacement System components are intended for uncemented use. .
| Prescription Use __YES | AND/OR | Over-The-Counter Use __NO |
|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 807 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Anton E. Dmitriev, PhD Division of Orthopedic Devices 2012.11.20 12:53:12 -05'00'