Who is the manufacturer of SEGMENTAL DEFECT REPLACEMENT SYSTEM?

Metagen, LLC filed the 510(k) submission for SEGMENTAL DEFECT REPLACEMENT SYSTEM (K980609).

What is the FDA product code for SEGMENTAL DEFECT REPLACEMENT SYSTEM?

HSB. It is classified under 21 CFR 888.3020 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for SEGMENTAL DEFECT REPLACEMENT SYSTEM?

510(k) clearance (submission type: Traditional).

What are the predicate devices for SEGMENTAL DEFECT REPLACEMENT SYSTEM?

EZ-Fix Midshaft Humeral Intramedullary Rod System (K962553); Howmedica Modular Proximal Humerus Replacement System (K954559).

Who can help prepare an FDA 510(k) submission like SEGMENTAL DEFECT REPLACEMENT SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

SEGMENTAL DEFECT REPLACEMENT SYSTEM

K980609 · Metagen, LLC · HSB · May 18, 1998 · Orthopedic

Device Facts

Record ID	K980609
Device Name	SEGMENTAL DEFECT REPLACEMENT SYSTEM
Applicant	Metagen, LLC
Product Code	HSB · Orthopedic
Decision Date	May 18, 1998
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3020
Device Class	Class 2
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.

Indications for Use

Indicated for pathologic fractures or impending pathologic fractures of the humeral diaphysis secondary to metastatic bone disease and hematologic malignancies.

Regulatory Classification

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)
Howmedica Modular Proximal Humerus Replacement System (K954559)

Reference Devices

Modular Oncology System Technology (K960626)
SOS Proximal Femur (K933281)
Modular Intercalary Humeral Spacer (Mayo Clinic)

Related Devices

K954559 — HOWMEDICCA MODULAR PROXIMAL HUMERUS REPLACEMENT SYSTEM · Howmedica Corp. · Jul 12, 1996
K043505 — DISCOVERY-MOSAIC TOTAL HUMERUS SYSTEM · Biomet, Inc. · Feb 9, 2005
K111746 — COMPREHENSIVE SEGMENTAL REVISION SYSTEM (SRS) · Biomet, Inc. · Dec 15, 2011
K113303 — OSLEOBRIDGE IDSF SPACER CONECTOR · Merete Medical GmbH · Dec 9, 2011
K143659 — Equinoxe Mega Prosthesis · Exactech, Inc. · Apr 9, 2015

Submission Summary (Full Text)

{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. {1}------------------------------------------------ t ﻟﻤﺴﺎﻋﺔ ﺍﻟ ## 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 {4}------------------------------------------------ #### 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) �� Prescription Use _X OR Over-the-Counter Use signature on Sion-Off Division of General Restorative I 510(k) Number