(21 days)
The Compress® Segmental Femoral Replacement System is indicated for:
- 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.
The Compress® Seqmental Anti-Rotation Spindles are not joint replacements but rather a method of fixing a segmental joint replacement to the patient's host bone. It utilizes the same spring-enhanced, stress-sharing design as the predicate Compress® Segmental Femoral Replacement System to generate stress on the host bone which helps prevent bone atrophy and promotes bone growth. It is intended to be used in conjunction with a knee or hip implant.
The complete device consists of an anchor plug, a spindle and either a proximal or distal femoral component. This 510(k) addresses modifications to the spindles. Holes are being added to the collar of the spindles to allow placement of pins to prevent rotation of the initial weeks following implantation. Additional sizes of spindles are also being added to the line.
The provided text describes modifications to an existing medical device, the Compress® Segmental Anti-Rotation Spindles, and its substantial equivalence to predicate devices. It does not contain information about a study proving the device meets acceptance criteria against specific performance metrics involving human readers or a standalone algorithm. The device, which is a method of fixing a segmental joint replacement, underwent non-clinical testing.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Resistance to rotational torque (implied acceptance: comparable to predicate) | "demonstrated that the device will functional within its intended use compared to the predicate device." |
| Engineering analyses (implied acceptance: greater wall thickness, smaller pin holes met) | "demonstrated that the device will functional within its intended use compared to the predicate device." (Specific values not provided, only that they were analyzed and deemed functional) |
2. Sample Size Used for the Test Set and Data Provenance
The document states "Non-Clinical Testing: Mechanical testing (resistance to rotational torque) and engineering analyses (greater wall thickness, smaller pin holes) of the Compress® Segmental Anti-Rotation Spindles demonstrated that the device will functional within its intended use compared to the predicate device."
- Test Set Sample Size: Not specified. The testing was mechanical and engineering analysis, not involving a population sample in the typical sense.
- Data Provenance: Not specified, but given it's mechanical and engineering testing, it would be laboratory-generated data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. The testing was non-clinical, mechanical, and engineering analysis. Ground truth for such tests is typically established by engineering specifications and physical measurements, not expert consensus in the medical image interpretation context.
4. Adjudication Method for the Test Set
Not applicable. There was no human interpretation or ground truth establishment based on expert consensus for this non-clinical testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
"Clinical Testing: None provided as a basis for substantial equivalence."
Therefore, no MRMC comparative effectiveness study was done.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This device is a physical medical implant, not a software algorithm.
7. Type of Ground Truth Used
For the non-clinical testing, the "ground truth" was based on engineering specifications and physical testing results (e.g., measurements of rotational torque, wall thickness, pin hole size) compared to the predicate device's performance and design.
8. Sample Size for the Training Set
Not applicable. This device is a physical medical implant, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a physical device.
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101475
Image /page/0/Picture/1 description: The image shows the logo for BIOMET MANUFACTURING CORP. The word "BIOMET" is in a stylized font with each letter enclosed in a box. The words "MANUFACTURING CORP." are printed in a simple sans-serif font below the logo.
.
510(k) Summary
| Preparation Date: | 6/16/10 | |
|---|---|---|
| Applicant/Sponsor: | Biomet Manufacturing Corp.56 East Bell DriveP.O. Box 587Warsaw, Indiana 46581-0587 | JUN 1 8 2010 |
| Contact Person: | Patricia Sandborn BeresSenior Regulatory Specialist | |
| Proprietary Name: | Compress® Segmental Anti-Rotation Spindles | |
| Common Name: | Segmental Femoral Stem Component | |
| Classification Name: | JDL, Hip joint metal/metal semi-constrained, with a cemented acetabularcomponent, prosthesis (21 CFR §888.3320)KWA, Hip joint metal/metal semi-constrained, with an uncementedacetabular component, prosthesis (21 CFR §888.3330)Hip Joint, Metal/Polymer, Semi-Constrained, Cemented Prosthesis(21 CFR §888.3350)Knee Joint, Femorotibial, Metal/Polymer Constrained, Cemented Prosthesis(21 CFR §888.3510) | |
| The compatible components included in this submission have the followingclassifications: | ||
| Subsequent Product Codes: | JDI, Hip Joint, Metal/Polymer, Semi-Constrained, Cemented Prosthesis(21 CFR §888.3350)KRO, Knee joint femorotibial metal/polymer constrained cementedprosthesis (21 CFR §888.3510)KWY, Hip joint femoral (hemi-hip) metal/polymer cemented oruncemented prosthesis (21 CFR §888.3390)KWZ, Hip joint metal/polymer constrained cemented or uncementedprosthesis (21 CFR §888.3310)LPH, Hip joint metal/polymer/metal semi-constrained porous-coateduncemented prosthesis (21 CFR §888.3358)LZO, Hip joint metal/ceramic/polymer semi-constrained cemented ornonporous uncemented prosthesis (21 CFR §888.3353)LZY, Hip joint (hemi-hip) acetabular metal cemented prosthesis (21 CFR§888.3370)MEH, Hip joint metal/ceramic/polymer semi-constrained cemented ornonporous uncemented prosthesis (21 CFR §888.3353) |
Malling Addresse:
Profilian Birlingson
Profilian Birlings (1982) Posted on September 1992
Del Comments (1982) Politics (1992)
Biografia (1992) Biografia (1972)
Status
Shipping Address!
56 East Bell Osse
Worsen, IN 46393
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Biomet Manufacturing Corp. Compress® Segmental Anti-Rotation Spindles Page 2 of 2
Legally Marketed Devices To Which Substantial Equivalence Is Claimed:
Compress® Segmental Femoral Replacement System (Short Spindle and Anchor Plugs) - K062998 Compress® Segmental Femoral Replacement System - K043547
Device Description: The Compress® Seqmental Anti-Rotation Spindles are not joint replacements but rather a method of fixing a segmental joint replacement to the patient's host bone. It utilizes the same spring-enhanced, stress-sharing design as the predicate Compress® Segmental Femoral Replacement System to generate stress on the host bone which helps prevent bone atrophy and promotes bone growth. It is intended to be used in conjunction with a knee or hip implant.
The complete device consists of an anchor plug, a spindle and either a proximal or distal femoral component. This 510(k) addresses modifications to the spindles. Holes are being added to the collar of the spindles to allow placement of pins to prevent rotation of the initial weeks following implantation. Additional sizes of spindles are also being added to the line.
Intended Use: The Compress® Segmental Femoral Replacement System is indicated for:
-
- Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
-
- Tumor resections.
- · 3. Revision of previously failed total joint arthroplasty.
- 4. Trauma.
The Compress® Segmental Femoral Replacement System components are intended for uncemented use.
Summary of Technologies: The Compress® Seqmental Anti-Rotation Spindles incorporate the same technology as the predicate devices.
Non-Clinical Testing: Mechanical testing (resistance to rotational torque) and engineering analyses (greater wall thickness, smaller pin holes) of the Compress® Segmental Anti-Rotation Spindles demonstrated that the device will functional within its intended use compared to the predicate device.
Clinical Testing: None provided as a basis for 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 features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Biomet Manufacturing Corporation % Ms. Patricia Sandborn Beres Senior Regulatory Specialist 56 East Bell Drive, P.O. Box 587 Warsaw, Indiana 46581-0587
JUN 1 8 2010
Re: K101475 Trade/Device Name: Compress® Segmental Anti-Rotation Spindles Regulation Number: 21 CFR 888.3330 Regulation Name: Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis Regulatory Class: III Product Codes: KWA, JDL, KRO, KWZ, JDI, LZO, MEH, LPH, KWY Dated: May 26, 2010 Received: May 28, 2010
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. Iisting 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
CFR Part 807); labeling (21 CFR Part 801); medical device 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/CDRH0ffices/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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Sincerely yours,
Barbara buel
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K101475
Device Name: Compress® Segmental Anti-Rotation Spindles
Indications for Use:
The Compress® Segmental Femoral Replacement System is indicated for:
-
- 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.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use NO (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)
Jouetu for mxm
. Prision Sign-Division of Surgical, Orthopedia, and Restorative Devices
510(k) Number K101475
Page 1 of 1
§ 888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.
(a)
Identification. A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two-part device intended to be implanted to replace a hip 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 consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027).(b)
Classification. Class III.(c)
Date PMA or notice of completion of PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 18, 2016, for any hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976, or that has, on or before May 18, 2016, been found to be substantially equivalent to a hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976. Any other hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.