(29 days)
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.
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.
The information provided states that no clinical or non-clinical data was submitted or deemed necessary for the determination of substantial equivalence for the Compress® Segmental Humeral Replacement System. Therefore, there is no study that proves the device meets specific acceptance criteria based on performance data.
Instead, the submission relied on demonstrating substantial equivalence to a predicate device (Compress® Segmental Humeral Replacement System, K112905) for an addition of compatibility to another system.
Given this, I cannot provide the requested information:
- A table of acceptance criteria and the reported device performance: No performance data or acceptance criteria are mentioned.
- Sample size used for the test set and the data provenance: No test set or data provenance mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No test set or ground truth established by experts mentioned.
- Adjudication method for the test set: No test set or adjudication method mentioned.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is a medical implant, not an AI diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a medical implant.
- The type of ground truth used: No ground truth used.
- The sample size for the training set: No training set mentioned.
- How the ground truth for the training set was established: No training set or ground truth mentioned.
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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 BeresSenior Regulatory SpecialistBiomet 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 SystemK112905 |
| Reason for 510(k) submission | Add compatibility to the Comprehensive® Segmental RevisionSystem (SRS), 510(k) 111746. |
| Device description | The Compress® Segmental Humeral Replacement System is ametallic segmental fixation system intended to replace theresected part of the humerus in cases of severe bone loss. TheCompress® Segmental Humeral Replacement Systemcomponents are intended for uncemented use. The design ofthe Compress® System allows a compressive load to be appliedat the prosthetic implant-bone interface at the time of deviceinsertion. This is accomplished through a spring system builtinto 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
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| Indications for use | The Compress® Segmental Humeral Replacement System is indicated for:1. Correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.2. Tumor resections.3. Revision of previously failed total joint arthroplasty.4. 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. |
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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
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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
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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'
§ 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.”