← Product Code [HSB](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSB) · K980609
# SEGMENTAL DEFECT REPLACEMENT SYSTEM (K980609)
_Metagen, LLC · HSB · May 18, 1998 · Orthopedic · SESE_
**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSB/K980609
## Device Facts
- **Applicant:** Metagen, LLC
- **Product Code:** [HSB](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSB.md)
- **Decision Date:** May 18, 1998
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 888.3020
- **Device Class:** Class 2
- **Review Panel:** Orthopedic
- **Attributes:** Therapeutic
## 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.
## Device Story
Segmental Defect Replacement System; modular bistemmed intramedullary rod system; used for reconstruction of humeral diaphysis following resection of diseased bone segments due to metastatic disease, myeloma, or lymphoma. Device components cemented into proximal and distal humeral segments; rigid cam locking mechanism allows intraoperative adjustment after cementing. Instrumentation provided to facilitate insertion. Used in clinical/surgical settings by physicians. Provides structural support to humerus; prevents pathologic fracture; restores limb function. Benefits patient by replacing diseased bone segments with stable, adjustable prosthetic construct.
## Clinical Evidence
Bench testing only. Static and fatigue mechanical testing performed to demonstrate substantial equivalence to predicate devices.
## Technological Characteristics
Modular bistemmed intramedullary rod system. Materials: Ti-6Al-4V, NiTi alloy (locking system). Rigid cam locking mechanism. Intended for use with bone cement. Mechanical fixation via intramedullary rods.
## Regulatory 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.
## Predicate Devices
- EZ-Fix Midshaft Humeral Intramedullary Rod System ([K962553](/device/K962553.md))
- Howmedica Modular Proximal Humerus Replacement System ([K954559](/device/K954559.md))
## Reference Devices
- Modular Oncology System Technology ([K960626](/device/K960626.md))
- SOS Proximal Femur ([K933281](/device/K933281.md))
- Modular Intercalary Humeral Spacer (Mayo Clinic)
## Submission Summary (Full Text)
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# 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 |
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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.
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### 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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**Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSB/K980609](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSB/K980609)
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