(21 days)
Not Found
No
The document describes a mechanical orthopedic implant and its modifications, with no mention of AI or ML technology in its function, design, or testing.
No
Explanation: The device is a segmental femoral replacement system intended to fix a segmental joint replacement to the patient's host bone and is used in conjunction with a knee or hip implant. It is an implantable medical device used for structural support and replacement, not for therapy.
No
Explanation: The device description and intended use clearly state that the Compress® Segmental Femoral Replacement System is a surgical implant used for bone replacement and fixation, not for diagnosing medical conditions. It performs a therapeutic function (bone reconstruction), not a diagnostic one (identifying a disease or condition).
No
The device description clearly outlines physical components (anchor plug, spindle, femoral component) and mechanical testing, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The Compress® Segmental Femoral Replacement System is a surgical implant intended for replacing or fixing parts of the femur (thigh bone). It is used in vivo (within the body) during surgery.
- Intended Use: The intended uses listed (correction of unsuccessful procedures, tumor resections, revision of failed arthroplasty, trauma) are all surgical procedures performed directly on the patient's body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, diagnostic testing, or any function related to providing information about a patient's health status based on laboratory analysis.
Therefore, the Compress® Segmental Femoral Replacement System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
KWA, JDL, KRO, KWZ, JDI, LZO, MEH, LPH, KWY
Device Description
The Compress® Segmental 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee, Hip
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 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.
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.
Not Found
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
§ 888.3330 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.
0
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 Drive | ||
| P.O. Box 587 | ||
| Warsaw, Indiana 46581-0587 | JUN 1 8 2010 | |
| Contact Person: | Patricia Sandborn Beres | |
| Senior 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 acetabular | |
| component, prosthesis (21 CFR §888.3320) | ||
| KWA, Hip joint metal/metal semi-constrained, with an uncemented | ||
| acetabular 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 following | ||
| classifications: | ||
| Subsequent Product Codes: | JDI, Hip Joint, Metal/Polymer, Semi-Constrained, Cemented Prosthesis | |
| (21 CFR §888.3350) | ||
| KRO, Knee joint femorotibial metal/polymer constrained cemented | ||
| prosthesis (21 CFR §888.3510) | ||
| KWY, Hip joint femoral (hemi-hip) metal/polymer cemented or | ||
| uncemented prosthesis (21 CFR §888.3390) | ||
| KWZ, Hip joint metal/polymer constrained cemented or uncemented | ||
| prosthesis (21 CFR §888.3310) | ||
| LPH, Hip joint metal/polymer/metal semi-constrained porous-coated | ||
| uncemented prosthesis (21 CFR §888.3358) | ||
| LZO, Hip joint metal/ceramic/polymer semi-constrained cemented or | ||
| nonporous 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 or | ||
| nonporous 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
1
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.
2
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
3
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
4
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
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