(136 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and reprocessing of external fixation systems, with no mention of AI or ML.
Yes
The device is intended to "stabilize and provide treatment for fractures" and for "treatment of pediatric and adult fractures," which describes therapeutic uses.
No
Explanation: The provided text clearly states the device's intention is to "stabilize and provide treatment for fractures" and for "construction of an external fixation frame for the treatment of pediatric and adult fractures." This describes a therapeutic device, not a diagnostic one.
No
The device description explicitly states it consists of "various clamps, posts, and bars," which are physical hardware components used to construct external fixation frames.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that this device is an "External Fixation System" used to "stabilize and provide treatment for fractures of the small bones, such as the hand, wrist, forearm, foot, and ankle" and "long bone and pelvic fractures." This involves physically supporting and stabilizing bones, not analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any analysis of biological specimens, chemical reactions, or diagnostic information derived from samples.
Therefore, the Medline Renewal Reprocessed Synthes External Fixation System is a surgical device used for orthopedic treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Medline Renewal Reprocessed Synthes Small External Fixation System is intended to stabilize and provide treatment for fractures of the small bones, such as the hand, wrist, forearm, foot, and ankle. Specifically, the components can be used for
- · Preliminary fixation before ORIF
- · Unstable fractures of the distal radius (both intra- and extra-articular)
- · Open and/or comminuted bilateral fractures
- · Fractures in combination with extensive soft tissue injury, bone loss, and vascular and/or neural involvement
· Fracture dislocations - · Failed closed reduction with casting resulting in secondary deformity (radial shortening and angulations)
- · Pediatric open fractures with bone loss and osteotomies.
Medline ReNewal Reprocessed Synthes Medium External Fixation System MR Conditional is intended for the construction of an external fixation frame for the treatment of pediatric and adult fractures.
Medline ReNewal Reprocessed Synthes Large External Fixation System is intended to provide treatment for long bone and pelvic fractures that require external fixation. Specifically, the components can be used for:
- · Stabilization of soft tissues and fractures
- · Polytrauma/multiple orthopedic trauma
- · Vertically stable pelvic fractures, or as a treatment adjunct for vertically unstable pelvic fractures
- · Arthrodeses and osteotomies with soft tissue problems; failures of total joints
- · Neutralization of fractures stabilized with limited internal fixation
- · Non-unions/septic non-unions
- · Intra-operative reductions/stabilization tool to assist with indirect reduction;
- · Unilateral rectilinear bone segment transport or leg lengthening
Medline ReNewal Reprocessed Synthes Distraction Osteogenesis System MR Conditional is intended for fracture fixation (open and closed), pseudoarthrosis or non-unions of long bones, limb lengthening by epiphyseal distraction, correction of bony or soft tissue deformities and correction of segmental bony or soft tissue defects in adult and pediatric patients.
Product codes (comma separated list FDA assigned to the subject device)
KTT
Device Description
The Medline ReNewal Reprocessed Synthes External Fixation Systems, devices consist of various clamps, posts, and bars, which are used to construct external fixation frames in the treatment of various types of fractures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Small bones (hand, wrist, forearm, foot, and ankle), long bones, pelvic fractures
Indicated Patient Age Range
Pediatric and adult fractures, adult and pediatric patients.
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 functional characteristics of the subject device have been evaluated and have been determined to be substantially equivalent to the predicate device based on the following tests:
• Functional performance studies:
o simulated use and artificial soiling; and
o structural integrity;
o carbon rod stiffness per the 4-point bend test (pre- conditioning);
o cyclical axial compression and tension bending test;
o carbon rod stiffness per the 4-point bend test (post conditioning); and
o disassembly and reassembly (pre-and post-sterilization).
• Cleaning:
o visual inspection;
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
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" above the word "ADMINISTRATION".
Surgical Instrument Service and Savings Inc November 9, 2017
Stephanie Boyle Mays Regulatory Specialist, Quality Assurance and Regulatory Affairs (dba Medline ReNewal) 1500 NE Hemlock Ave. Redmond, Oregon 97756
Re: K171911
Trade/Device Name: Medline ReNewal Reprocessed Synthes External Fixation Systems Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: KTT Dated: October 11, 2017 Received: October 12, 2017
Dear Stephanie Boyle Mays:
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, listing 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 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);
1
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Image /page/2/Picture/1 description: The image shows the Medline Renewal logo. The word "MEDLINE" is in blue and to the left of a blue star-like symbol. To the right of the Medline logo is the word "Renewal" in green and blue. Below the word "Renewal" is the phrase "Full Circle Reprocessing" in gray.
Traditional 510(k) Notification Medline ReNewal Reprocessed Synthes External Fixation Systems Devices
4.0 Indications for Use
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K171911
Device Name
Medine ReNewal Reprocessed Synthes External Fixation Systems
Indications for Use (Describe)
Medline Renewal Reprocessed Synthes Small External Fixation System is intended to stabilize and provide treatment for fractures of the small bones, such as the hand, wrist, forearm, foot, and ankle. Specifically, the components can be used for
- · Preliminary fixation before ORIF
- · Unstable fractures of the distal radius (both intra- and extra-articular)
- · Open and/or comminuted bilateral fractures
- · Fractures in combination with extensive soft tissue injury, bone loss, and vascular and/or neural involvement
· Fracture dislocations
- · Failed closed reduction with casting resulting in secondary deformity (radial shortening and angulations)
- · Pediatric open fractures with bone loss and osteotomies.
Medline ReNewal Reprocessed Synthes Medium External Fixation System MR Conditional is intended for the construction of an external fixation frame for the treatment of pediatric and adult fractures.
Medline ReNewal Reprocessed Synthes Large External Fixation System is intended to provide treatment for long bone and pelvic fractures that require external fixation. Specifically, the components can be used for:
- · Stabilization of soft tissues and fractures
- · Polytrauma/multiple orthopedic trauma
- · Vertically stable pelvic fractures, or as a treatment adjunct for vertically unstable pelvic fractures
- · Arthrodeses and osteotomies with soft tissue problems; failures of total joints
- · Neutralization of fractures stabilized with limited internal fixation
- · Non-unions/septic non-unions
- · Intra-operative reductions/stabilization tool to assist with indirect reduction;
- · Unilateral rectilinear bone segment transport or leg lengthening
Medline ReNewal Reprocessed Synthes Distraction Osteogenesis System MR Conditional is intended for fracture fixation (open and closed), pseudoarthrosis or non-unions of long bones, limb lengthening by epiphyseal distraction, correction of bony or soft tissue deformities and correction of segmental bony or soft tissue defects in adult and pediatric patients.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
FORM FDA 3881 (1/14)
3
Image /page/3/Picture/1 description: The image shows the Medline Renewal logo. The word "MEDLINE" is in blue and to the left of a blue star. To the right of the star is a vertical line, and to the right of the line is the word "ReNewal" in green and blue. Below the word "ReNewal" is the phrase "Full Circle Reprocessing" in blue.
Traditional 510(k) Notification Medline ReNewal Reprocessed Synthes External Fixation Systems Devices
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995. DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (1/14)
4
Image /page/4/Picture/0 description: The image shows the Medline Renewal logo. The word "Renewal" is written in a combination of green and blue colors, with "Re" in green and "Newal" in blue. Below "Renewal" is the text "Full Circle Reprocessing" in a smaller font size. To the left of the text is the Medline logo, which features the word "MEDLINE" next to a blue star-like symbol.
K171911 510(k) Summary
| Submitter/
Owner | Surgical Instrument Service and Savings (dba Medline ReNewal)
1500 NE Hemlock Ave.
Redmond, OR 97756 | | |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Prepared by | Stephanie Boyle Mays
Regulatory Affairs Specialist, Regulatory Affairs
P: 541-516-4205
F: 541-923-3375
E:smays@medline.com | | |
| Date Prepared | June 23, 2017 | | |
| Device Names | Proprietary Name: Medline ReNewal Reprocessed Synthes External
Fixation Systems Devices
Common Name: External Fixation Devices | | |
| Classification | Classification: Class II
Classification Name: Single/multiple component metallic bone fixation
appliances and accessories and smooth or threaded metallic bone fixation
fastener.
Regulation Number/Product Code: 888.3030/KTT | | |
| Primary
Predicate
Device | K122455 Synthes Small External Fixation System, Synthes Large External
Fixation System | | |
| Secondary
Predicate 1
Device | K090658 Synthes External Fixation Devices, MR conditional | | |
| Secondary
Predicate 2
Device | K092190 Synthes Distraction Osteogenesis System, MR Conditional with
Expanded Indications | | |
| Device
Description | The Medline ReNewal Reprocessed Synthes External Fixation Systems,
devices consist of various clamps, posts, and bars, which are used to
construct external fixation frames in the treatment of various types of
fractures. | | |
| Statement of
Intended Use | The Medline ReNewal Reprocessed Synthes External Fixation Systems
Devices are intended for use in the construction of an external fixation
frame for treatment of various fracture types that require external fixation. | | |
| Indications for
Use | Medline Renewal Reprocessed Synthes Small External Fixation System is
intended to stabilize and provide treatment for fractures of the small bones,
such as the hand, wrist, forearm, foot, and ankle. Specifically, the
components can be used for:
• Preliminary fixation before ORIF
• Unstable fractures of the distal radius (both intra- and extra-articular)
• Open and/or comminuted bilateral fractures
• Fractures in combination with extensive soft tissue injury, bone loss, and
vascular and/or neural involvement
• Fracture dislocations
• Failed closed reduction with casting resulting in secondary deformity | | |
5
Image /page/5/Picture/0 description: The image contains the logos for Medline and Renewal. The Medline logo is on the left and features the company name in blue with a stylized star symbol. To the right of the Medline logo is the Renewal logo, with "ReNewal" in green and blue, and the text "Full Circle Reprocessing" in a smaller font below it.
| | (radial shortening and angulations)
• Pediatric open fractures with bone loss and osteotomies |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The Medline ReNewal Reprocessed Synthes Medium External Fixation
System, MR Conditional is intended for the construction of an external
fixation frame for the treatment of pediatric and adult fractures. |
| | Medline ReNewal Reprocessed Synthes Large External Fixation System is
intended to provide treatment for long bone and pelvic fractures that require
external fixation. Specifically, the components can be used for:
• Stabilization of soft tissues and fractures
• Polytrauma/multiple orthopedic trauma
• Vertically stable pelvic fractures, or as a treatment adjunct for vertically
unstable pelvic fractures
• Arthrodeses and osteotomies with soft tissue problems; failures of total
joints
• Neutralization of fractures stabilized with limited internal fixation
• Non-unions/septic non-unions
• Intra-operative reductions/stabilization tool to assist with indirect reduction;
• Unilateral rectilinear bone segment transport or leg lengthening. |
| | Medline ReNewal Reprocessed Synthes Distraction Osteogenesis System,
MR Conditional is intended for fracture fixation (open and closed),
pseudoarthrosis or non-unions of long bones, limb lengthening by
epiphyseal or metaphyseal distraction, correction of bony or soft tissue
deformities and correction of segmental bony or soft tissue defects in adult
and pediatric patients. |
| Technological
Characteristics | The Medline ReNewal Reprocessed Synthes External Fixation Systems
Devices are rods, couplings, connectors, clamps, posts and accessories
that, when combined with other components, are used to build external
skeletal constructs for the devices intended use. The proposed device is a
reprocessed version of the predicate device and the technological
characteristics of these devices are substantially equivalent. |
| Performance
Testing | The functional characteristics of the subject device have been evaluated
and have been determined to be substantially equivalent to the predicate
device based on the following tests:
• Functional performance studies:
o simulated use and artificial soiling; and
o structural integrity;
o carbon rod stiffness per the 4-point bend test (pre-
conditioning);
o cyclical axial compression and tension bending test;
o carbon rod stiffness per the 4-point bend test (post
conditioning); and
o disassembly and reassembly (pre-and post-sterilization).
• Cleaning:
o visual inspection;
|
6
Image /page/6/Picture/0 description: The image contains the Medline Renewal logo. The word "Medline" is in blue, with a blue star to the left of the word. To the right of the Medline logo is the word "Renewal", with "Re" in green and "newal" in blue. Below the word Renewal is the phrase "Full Circle Reprocessing" in a smaller font.
Device Models
| Catalog
| No. | Description | |
|---|---|---|
| 393.64 | Adjustable Clamp (Lg) | |
| 393.66 | Transverse Clamp | |
| 393.76 | Open Compressor | |
| 394.055 | Elbow Hinge Fixator, MR Safe | |
| 390.002 | Lrg Ex-Fix Multi-Pin Clamp Mr-Conditional / 6-Position | |
| 390.004 | Lrg Ex-Fix Multi-Pin Clamp MR Conditional / 4-Position | |
| 390.010 | Lrg Ex-Fix Pin Clamp MR Conditional/ 6-Position | |
| 390.013 | Large Ex-Fix 90° Outrigger Post 11-mm/ MR Conditional | |
| 393.012 | Lrg Ex-Fix 30° Outrigger Post 11-mm/ MR Conditional | |
| 394.79 | Lrg Ex-Fix 11-mm Curved Crbn Fbr Rod-180°/MR | |
| Conditional | ||
| 394.791. | Lrg Ex-Fix 11-mm Curved Crbn Fbr Rod-45°/MR | |
| Conditional | ||
| 394.792 | Lrg Ex-Fix 11-mm Curved Crbn Fbr Rod-90°/MR | |
| Conditional | ||
| 394.793 | Lrg Ex-Fix 11-mm Curved Crbn Fiber Rod-135°/MR | |
| Conditional | ||
| 390.005 | Lrg Ex-Fix Combination Clamp MR Conditional | |
| 390.006 | Lrg Ex-Fix Dynamization Clamp F/Combo Clamp/MR | |
| Conditional | ||
| 390.007 | Lrg Ex-Fix Tube-Tube Clamp MR Conditional | |
| 390.008 | Lrg Ex-Fix Open Adj Clamp MR Conditional | |
| 390.009 | Lrg Ex-Fix Pin clamp MR Conditional/4-position | |
| 390.011 | Lrg Ex-Fix Straight Outrigger Post 11-mm/MR | |
| Conditional | ||
| 390.003 | Lrg Ex-Fix Rod Attchmt/Multi Pin Clamp/MR Conditional | |
| 394.80 | Lrg Ex Fix 11-mm Crbn Fbr Rod 100-mm/MR | |
| Conditional | ||
| 394.81 | Lrg Ex-Fix 11-mm Crbn Fbr Rod 125-mm/MR | |
| Conditional | ||
| 394.82 | Lrg Ex-Fix 11-mm Crbn Fbr Rod 150-mm/MR | |
| Conditional | ||
| 394.83 | Lrg Ex-Fix 11-mm Crbn Fbr Rod 200-mm/MR | |
| Conditional | ||
| 394.84 | Lrg Ex-Fix 11-mm Crbn Fbr Rod 250-mm/MR | |
| Conditional | ||
| Catalog | ||
| No. | Description | |
| 394.85 | Lrg Ex-Fix 11-mm Crbn Fbr Rod 300-mm/MR | |
| Conditional | ||
| 394.86 | Lrg Ex-Fix 11-mm Crbn Fbr Rod 350-mm/MR | |
| Conditional | ||
| 394.87 | Lrg Ex-Fix 11-mm Crbn Fbr Rod 400-mm/MR | |
| Conditional | ||
| 394.88 | Lrg Ex-Fix 11-mm Crbn Fbr Rod 450-mm/MR | |
| Conditional | ||
| 394.89 | Lrg Ex-Fix 11-mm Crbn Fbr Rod 500-mm/MR | |
| Conditional | ||
| 394.90 | Lrg Ex-Fix 11-mm Crbn Fbr Rod 550-mm/MR | |
| Conditional | ||
| 394.91 | Lrg Ex-Fix 11-mm Crbn Fbr Rod 600-mm/MR | |
| Conditional | ||
| 394.92 | Lrg Ex-Fix 11-mm Crbn Fiber Rod 650-mm/MR | |
| Conditional | ||
| 390.041 | Small Ex-Fix Combination Clamp MR Conditional | |
| 395.680 | Small Ex-Fix 4-mm Curved Crbn Fiber Rod 60°/MR | |
| Conditional | ||
| 395.681 | Small Ex-Fix 4.0-mm Curved Crbn Fiber Rod 90°/MR | |
| Conditional | ||
| 395.682 | Small Ex-Fix 4.0mm Curved Crbn Fiber Rod-120°/MR | |
| Conditional | ||
| 395.60 | 4.0mm Carbon Fiber Rod 60mm (small) | |
| 395.61 | 4.0mm Carbon Fiber Rod 80mm | |
| 395.62 | 4.0mm Carbon Fiber Rod 100mm | |
| 395.63 | 4.0mm Carbon Fiber Rod 120mm | |
| 395.64 | 4.0mm Carbon Fiber Rod 140mm | |
| 395.65 | 4.0mm Carbon Fiber Rod 160mm | |
| 395.66 | 4.0mm Carbon Fiber Rod 180mm | |
| 395.67 | 4.0mm Carbon Fiber Rod 200mm | |
| 390.031 | Medium Combination Clamp, MR Conditional | |
| 390.032 | Dynamization Clip for Medium Combination clamp, MR | |
| Conditional | ||
| 390.033 | Medium Multi-Pin Clamp 4 Position, MR Conditional | |
| 390.036 | Medium Multi-Pin Clamp 6 Position, MR Conditional | |
| 390.037 | 8-mm/11-mm Combination Clamp, MR Conditional | |
| 390.026 | Medium Pin Clamp 4 Position, MR Conditional | |
| 390.027 | Medium Pin Clamp-6 Position, MR Conditional | |
| 390.034 | Rod Attachment For Medium Multi-Pin Clamp, MR | |
| Conditional | ||
| 390.035 | Medium Open Adjustable Clamp, MR Conditional | |
| 390.051 | 4-mm Adjustable Clamp For Distal Radius Fixator, MR | |
| Conditional | ||
| 395.779 | 8-mm Carbon Fiber Rod 160 mm | |
| 395.782 | 8-mm Carbon Fiber Rod 200 mm | |
| 395.784 | 8-mm Carbon Fiber Rod 220 mm | |
| 395.788 | 8-mm Carbon Fiber Rod 280 mm | |
| 395.792 | 8-mm Carbon Fiber Rod 320 mm | |
| 395.796 | 8-mm Carbon Fiber Rod 360 mm | |
| 395.797 | 8-mm Carbon Fiber Rod 400 mm | |
| 395.78 | 4-mm Connecting Bar 220 mm | |
| 395.798 | 8-mm Carbon Fiber Rod 460 mm | |
| 393.361 | Tube-To-Tube Clamp | |
| 393.36 | Tube-To-Tube Clamp | |
| 390.030 | 90° Outrigger Post 8mm, MR Conditional | |
| 390.028 | Straight Outrigger Post 8 mm, MR Conditional | |
| 390.029 | 30° Outrigger Post 8 mm, MR Conditional | |
| 03.311.058 | Schanz Screw Bolt Cannulated Ring Mount, MR Conditional | |
| 03.311.059 | Schanz Screw Bolt Cannulated Post Mount, MR Conditional | |
| 03.311.081 | Spacing Washer 1mm, MR Conditional | |
| 03.311.082 | Spacing Washer 2mm, MR Conditional | |
| 03.311.084 | Spacing Washer 4mm, MR Conditional | |
| 03.311.112 | Threaded Rod 120mm, MR Conditional | |
| 03.311.115 | Threaded Rod 150mm, MR Conditional | |
| 03.311.120 | Threaded Rod 200mm, MR Conditional | |
| 03.311.125 | Threaded Rod 250mm Long, MR Conditional | |
| 03.311.130 | Threaded Rod 300mm Long, MR Conditional | |
| 03.311.135 | Threaded Rod 350mm Long, MR Conditional | |
| 03.311.140 | Threaded Rod 400mm Long, MR Conditional | |
| 03.311.201 | Connecting Plate/1 Hole, MR Conditional | |
| 03.311.202 | Connecting Plate/2 Holes, MR Conditional | |
| 03.311.203 | Connecting Plate/3 Holes, MR Conditional | |
| 03.311.204 | Connecting Plate/4 Holes, MR Conditional | |
| 03.311.220 | Standoff 20 mm Long, MR Conditional | |
| 03.311.230 | Standoff 30 mm Long, MR Conditional | |
| 03.311.240 | Standoff 40 mm Long, MR Conditional | |
| 03.311.250 | Standoff 50 mm Long, MR Conditional | |
| Conclusion | Based on a comparison of the indications for use, intended use, | |
| technological characteristics, and performance data to the predicate, | ||
| reference 1 and reference 2 devices, Medline ReNewal Reprocessed | ||
| Synthes External Fixation Devices are substantially equivalent to the predicate device |
7
8
Image /page/8/Picture/0 description: The image shows the Medline Renewal logo. The word "Medline" is in blue, with a blue star-like symbol to the right of it. To the right of the Medline logo is a vertical line, and then the word "Renewal" in green and blue. Below the word "Renewal" is the phrase "Full Circle Reprocessing" in a smaller, blue font.