(90 days)
No
The document describes a mechanical implant system and does not mention any AI or ML components or functionalities.
Yes
The device is intended for the reconstruction of the humeral diaphysis due to extensive bone lesions, addressing pathologic fractures or impending pathologic fractures, which is a therapeutic purpose.
No
Explanation: The device is a surgical implant designed for reconstruction of the humeral diaphysis, replacing a diseased bone segment. It is a treatment device, not one that identifies or diagnoses a condition.
No
The device description clearly states it is a system of intramedullary rods, a locking device, and instrumentation, all made of physical materials (Ti-6Al-4V NiTi alloy). This indicates it 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:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases, conditions, or infections.
- Device Description: The Segmental Defect Replacement System is a physical implant designed to replace a section of bone (humeral diaphysis) and provide structural support. It is used in vivo (within the body) during surgery.
- Intended Use: The intended use describes the surgical reconstruction of a bone defect and fixation, not the analysis of biological samples.
Therefore, this device falls under the category of a surgical implant or orthopedic device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Segmental Defect Replacement System, when used with bone cement, is intended for reconstruction of the humeral diaphysis with an extensive bone lesion due to metastatic disease, myeloma, or lymphoma, that places the humerus at risk for pathologic fracture.
The Clinical Indication for Use is:
"The Segmental Defect Replacement System, when used with bone cement, is indicated for pathologic fractures or impending pathologic fractures of the diaphysis of the humerus secondary to metastatic bone disease and hematologic malignancies."
Product codes (comma separated list FDA assigned to the subject device)
87HSB
Device Description
The Segmental Defect Replacement System is an array of proximal and distal intramedullary rods which, when locked together, replace the resected diseased segment and fixation in the remaining humeral bone The system includes a locking device to secure the rod components, and instrumentation to facilitate stock. insertion.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Humeral diaphysis, 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)
The Segmental Defect Replacement System has been evaluated by use of the static and fairgue tests. It has been shown to be substantially equivalent to the predicate devices.
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.
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
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.
0
510(k) Summary
Segmental Defect Replacement System
510(k) Summary prepared February 12, 1998
MANUFACTURER IDENTIFICATION
Metagen, LLC 428 Technology Drive East Menomonie, Wisconsin 54751
Official Contact Person Wesley D. Johnson President Telephone (715) 232-4880 Fax (715) 235-9570
Consultant/Representative Floyd G. Larson Pacific Materials and Interfaces 4329 Graydon Road San Diego, CA 92130 Telephone (619) 792-1235 Fax (619) 792-1235
DEVICE IDENTIFICATION
Proprietary Name Segmental Defect Replacement System
Common Name Segmental Defect Prosthesis
Classification Name and Reference Rod, Fixation, Intramedullary and Accessories, 21CFR 888.3020
Regulatory Classification
The Orthopedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee of FDA has recommended Class II, Performance Standards, for this device.
Device Product Codes
Product Code 87HSB has been assigned to this device.
DEVICE DESCRIPTION
Intended Use
The Segmental Defect Replacement System, when used with bone cement, is intended for reconstruction of the humeral diaphysis with an extensive bone lesion due to metastatic disease, myeloma, or lymphoma, that places the humerus at risk for pathologic fracture.
Design
The Segmental Defect Replacement System is an array of proximal and distal intramedullary rods which, when locked together, replace the resected diseased segment and fixation in the remaining humeral bone The system includes a locking device to secure the rod components, and instrumentation to facilitate stock. insertion.
Mechanical Characterization
The Segmental Defect Replacement System has been evaluated by use of the static and fairgue tests. It has been shown to be substantially equivalent to the predicate devices.
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SUMMARY: TABLE OF SUBSTANTIAL EQUIVALENCE
The Segmental Defect Replacement System is substantially equivalent to the following predicate devices:
| Subject Device | Predicate Devices | Related Devices | |||
|---|---|---|---|---|---|
| Segmental Defect | |||||
| Replacement System | EZ-Fix Midshaft | ||||
| Humeral | |||||
| Intramedullary Rod | |||||
| System. | |||||
| Biodynamics | |||||
| Technologies, Inc. | |||||
| (K962553) | Howmedica Modular | ||||
| Proximal Humerus | |||||
| Replacement System. | |||||
| Howmedica | |||||
| (K954559) | Modular Oncology | ||||
| System Technology. | |||||
| Intermedics | |||||
| Orthopedics, Inc. | |||||
| (Sulzer Orthopedics) | |||||
| (K960626) | SOS Proximal Femur. | ||||
| Wright Medical | |||||
| Technology | |||||
| (K933281) | Modular Intercalary Humeral | ||||
| Spacer. | |||||
| Mayo Clinic | |||||
| Intended Use | |||||
| Reconstruction of the | |||||
| humeral diaphysis with | |||||
| an extensive destructive | |||||
| bone lesion due to | |||||
| metastatic disease, | |||||
| myeloma, or lymphoma, | |||||
| that places the humerus | |||||
| at risk for pathologic | |||||
| fracture | Midshaft fractures of | ||||
| the humerus | Replacements of the | ||||
| proximal humerus | |||||
| secondary to | |||||
| extensive bone loss or | |||||
| bone disease. Bone | |||||
| loss can be due to | |||||
| tumor resection, | |||||
| revision arthroplasty | |||||
| or trauma. | Replacement of the | ||||
| proximal, distal or total | |||||
| femur where the amount | |||||
| of femoral resection and | |||||
| restoration is extreme | |||||
| (e.g., in oncology | |||||
| cases). | Procedures in which a | ||||
| variable resection length | |||||
| prosthesis is necessary to | |||||
| accommodate the | |||||
| condition of the femur, | |||||
| e.g., severe bone loss in | |||||
| hip arthroplasty for | |||||
| osteosarcoma or fractured | |||||
| femur or revision | |||||
| arthroplasty. | Pathological fracture, | ||||
| impending pathological | |||||
| fracture or failure of | |||||
| attempted internal fixation | |||||
| techniques secondary to | |||||
| segmental destructive bone | |||||
| lesions of the humeral | |||||
| diaphysis in disseminated | |||||
| malignancies | |||||
| Design | |||||
| Modular bistemmed | |||||
| intramedullary rod | |||||
| system with rigid cam | |||||
| locking mechanism | |||||
| designed to provide | |||||
| intraoperative adjustment | |||||
| after cementing | |||||
| components into the | |||||
| proximal and distal | |||||
| segments of the resected | |||||
| humerus. | Intramedullary rod | ||||
| system with screw | |||||
| holes, to be used | |||||
| without bone cement | Modular humeral | ||||
| replacement system, | |||||
| consisting of head, | |||||
| body and stem | |||||
| segments. Cemented. | Modular hip and knee | ||||
| system consisting of a | |||||
| proximal femoral | |||||
| replacement, | |||||
| intramedullary stems | |||||
| and femoral segments, a | |||||
| distal femoral | |||||
| replacement which | |||||
| mates with a tibial | |||||
| component, and a | |||||
| patella. | Modular hip system | ||||
| consisting of a femoral | |||||
| neck component, an | |||||
| optional mid-section | |||||
| component and a stem | |||||
| component with Morse | |||||
| taper connections. | |||||
| Cemented. | Modular bistemmed | ||||
| intramedullary rod system | |||||
| with conical coupling | |||||
| mechanism locked with set | |||||
| screws designed to provide | |||||
| intraoperative adjustment | |||||
| after cementing components | |||||
| into the proximal and distal | |||||
| segments of the resected | |||||
| humerus. | |||||
| Materials | |||||
| Ti-6Al-4V | |||||
| NiTi alloy (locking | |||||
| system) | Ti-6Al-4V | Co-Cr-Mo alloy (head | |||
| and stem) | |||||
| Ti alloy (body) | Ti-6Al-4V | ||||
| UHMWPE (patella) | Ti-6Al-4V | Ti-6Al-4V |
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 8 1998
Mr. Wesley D. Johnson President Metagen, LLC 428 Technology Drive East Menomonie, Wisconsin 54751
Re : K980609 Trade Name: Segmental Defect Replacement System Regulatory Class: II Product Code: нав Dated: February 17, 1998 Received: February 17, 1998
Dear Mr. Johnson:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. पुर substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Mr. Wesley D. Johnson
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M
Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Device Name: SEGMENTAL DEFECT REPLACEMENT SYSTEM、 长980609
The Segmental Defect Replacement System, when used with bone cement, is intended for reconstruction of the humeral diaphysis with an extensive desion due to metastatic disease, myeloma, or lymphoma, that places the humerus at risk for pathologic fracture.
The Clinical Indication for Use is:
"The Segmental Defect Replacement System, when used with bone cement, is indicated for pathologic fractures or impending pathologic fractures of the diaphysis of the humerus secondary to metastatic bone disease and hematologic malignancies."
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Prescription Use _X
OR
Over-the-Counter Use
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on Sion-Off Division of General Restorative I 510(k) Number