(136 days)
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.
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.
This document, K171911, is a 510(k) premarket notification for Medline ReNewal Reprocessed Synthes External Fixation Systems. It focuses on demonstrating substantial equivalence to predicate devices, primarily through performance testing related to the reprocessing of the devices. The document does not describe an artificial intelligence (AI) device or a study involving human readers and AI assistance for diagnostic purposes.
Therefore, many of the requested items related to AI device performance, sample sizes for test/training sets, expert ground truth establishment, and multi-reader multi-case studies are not applicable to the content of this regulatory submission.
However, I can extract information regarding the performance testing conducted to prove the reprocessing meets the acceptance criteria for substantial equivalence to the original devices.
Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Medline ReNewal Reprocessed Synthes External Fixation Systems are based on demonstrating functional equivalence to the predicate (new, un-reprocessed) devices. The testing performed evaluates the integrity and cleanliness of the reprocessed devices.
| Acceptance Criteria Category | Specific Test/Evaluation | Reported Device Performance |
|---|---|---|
| Functional Performance | Simulated use and artificial soiling | Determined to be substantially equivalent to the predicate device. |
| Structural integrity | Determined to be substantially equivalent to the predicate device. | |
| Carbon rod stiffness (pre-conditioning, 4-point bend test) | Determined to be substantially equivalent to the predicate device. | |
| Cyclical axial compression and tension bending test | Determined to be substantially equivalent to the predicate device. | |
| Carbon rod stiffness (post-conditioning, 4-point bend test) | Determined to be substantially equivalent to the predicate device. | |
| Disassembly and reassembly (pre- and post-sterilization) | Determined to be substantially equivalent to the predicate device. | |
| Cleaning | Visual inspection | Determined to be substantially equivalent to the predicate device. |
Please note: The document states "Determined to be substantially equivalent to the predicate device" for each test. It does not provide specific numerical results or pass/fail thresholds for these tests within the provided text. The implication is that the reprocessed devices performed comparably to new devices.
Study Details (as applicable to this non-AI medical device reprocessing submission)
-
Sample size used for the test set and the data provenance:
- The document does not explicitly state the sample size (number of reprocessed units) for each test. These are typically bench tests.
- Data Provenance: The tests were conducted by Medline ReNewal (Surgical Instrument Service and Savings) as part of their 510(k) submission, implying an internal, prospective study to support regulatory clearance. The country of origin for the data is implicitly the USA, where Medline ReNewal is based and operates.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This concept is not directly applicable to the functional and cleaning tests performed on reprocessed medical devices. Ground truth here is defined by performance specifications for new devices, and the acceptance criteria are met if the reprocessed devices perform equivalently to these specifications. No "experts" in the sense of clinicians or radiologists establishing a diagnostic ground truth are mentioned or needed for these types of engineering/performance tests.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are typically used in clinical or diagnostic studies to resolve discordant readings among multiple human annotators, which is not the nature of this submission's testing.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No, a MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human diagnostic performance, which is not the subject of this 510(k) submission. This submission concerns the substantial equivalence of reprocessed surgical instruments to their new counterparts.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This submission is not for an AI algorithm. The performance testing is for physical medical devices after reprocessing.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this study is the established performance specifications and characteristics of equivalent new, un-reprocessed Synthes External Fixation Systems (the predicate devices). The reprocessed devices are tested to show they meet these same performance levels. It's a comparison to an accepted standard for new devices, not a diagnostic ground truth based on patient outcomes or expert reads.
-
The sample size for the training set:
- Not applicable. There is no "training set" as this is not an AI/machine learning device.
-
How the ground truth for the training set was established:
- Not applicable. As there is no training set, this question is not relevant.
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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);
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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
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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)
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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)
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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 MaysRegulatory Affairs Specialist, Regulatory AffairsP: 541-516-4205F: 541-923-3375E:smays@medline.com | ||
| Date Prepared | June 23, 2017 | ||
| Device Names | Proprietary Name: Medline ReNewal Reprocessed Synthes ExternalFixation Systems DevicesCommon Name: External Fixation Devices | ||
| Classification | Classification: Class IIClassification Name: Single/multiple component metallic bone fixationappliances and accessories and smooth or threaded metallic bone fixationfastener.Regulation Number/Product Code: 888.3030/KTT | ||
| PrimaryPredicateDevice | K122455 Synthes Small External Fixation System, Synthes Large ExternalFixation System | ||
| SecondaryPredicate 1Device | K090658 Synthes External Fixation Devices, MR conditional | ||
| SecondaryPredicate 2Device | K092190 Synthes Distraction Osteogenesis System, MR Conditional withExpanded Indications | ||
| DeviceDescription | The Medline ReNewal Reprocessed Synthes External Fixation Systems,devices consist of various clamps, posts, and bars, which are used toconstruct external fixation frames in the treatment of various types offractures. | ||
| Statement ofIntended Use | The Medline ReNewal Reprocessed Synthes External Fixation SystemsDevices are intended for use in the construction of an external fixationframe for treatment of various fracture types that require external fixation. | ||
| Indications forUse | Medline Renewal Reprocessed Synthes Small External Fixation System isintended to stabilize and provide treatment for fractures of the small bones,such as the hand, wrist, forearm, foot, and ankle. Specifically, thecomponents 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, andvascular and/or neural involvement• Fracture dislocations• Failed closed reduction with casting resulting in secondary deformity |
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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 FixationSystem, MR Conditional is intended for the construction of an externalfixation frame for the treatment of pediatric and adult fractures. | |
| Medline ReNewal Reprocessed Synthes Large External Fixation System isintended to provide treatment for long bone and pelvic fractures that requireexternal 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 verticallyunstable pelvic fractures• Arthrodeses and osteotomies with soft tissue problems; failures of totaljoints• 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 byepiphyseal or metaphyseal distraction, correction of bony or soft tissuedeformities and correction of segmental bony or soft tissue defects in adultand pediatric patients. | |
| TechnologicalCharacteristics | The Medline ReNewal Reprocessed Synthes External Fixation SystemsDevices are rods, couplings, connectors, clamps, posts and accessoriesthat, when combined with other components, are used to build externalskeletal constructs for the devices intended use. The proposed device is areprocessed version of the predicate device and the technologicalcharacteristics of these devices are substantially equivalent. |
| PerformanceTesting | The functional characteristics of the subject device have been evaluatedand have been determined to be substantially equivalent to the predicatedevice based on the following tests:• Functional performance studies:o simulated use and artificial soiling; ando 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 (postconditioning); ando disassembly and reassembly (pre-and post-sterilization).• Cleaning:o visual inspection; |
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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
| CatalogNo. | 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°/MRConditional | |
| 394.791. | Lrg Ex-Fix 11-mm Curved Crbn Fbr Rod-45°/MRConditional | |
| 394.792 | Lrg Ex-Fix 11-mm Curved Crbn Fbr Rod-90°/MRConditional | |
| 394.793 | Lrg Ex-Fix 11-mm Curved Crbn Fiber Rod-135°/MRConditional | |
| 390.005 | Lrg Ex-Fix Combination Clamp MR Conditional | |
| 390.006 | Lrg Ex-Fix Dynamization Clamp F/Combo Clamp/MRConditional | |
| 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/MRConditional | |
| 390.003 | Lrg Ex-Fix Rod Attchmt/Multi Pin Clamp/MR Conditional | |
| 394.80 | Lrg Ex Fix 11-mm Crbn Fbr Rod 100-mm/MRConditional | |
| 394.81 | Lrg Ex-Fix 11-mm Crbn Fbr Rod 125-mm/MRConditional | |
| 394.82 | Lrg Ex-Fix 11-mm Crbn Fbr Rod 150-mm/MRConditional | |
| 394.83 | Lrg Ex-Fix 11-mm Crbn Fbr Rod 200-mm/MRConditional | |
| 394.84 | Lrg Ex-Fix 11-mm Crbn Fbr Rod 250-mm/MRConditional | |
| CatalogNo. | Description | |
| 394.85 | Lrg Ex-Fix 11-mm Crbn Fbr Rod 300-mm/MRConditional | |
| 394.86 | Lrg Ex-Fix 11-mm Crbn Fbr Rod 350-mm/MRConditional | |
| 394.87 | Lrg Ex-Fix 11-mm Crbn Fbr Rod 400-mm/MRConditional | |
| 394.88 | Lrg Ex-Fix 11-mm Crbn Fbr Rod 450-mm/MRConditional | |
| 394.89 | Lrg Ex-Fix 11-mm Crbn Fbr Rod 500-mm/MRConditional | |
| 394.90 | Lrg Ex-Fix 11-mm Crbn Fbr Rod 550-mm/MRConditional | |
| 394.91 | Lrg Ex-Fix 11-mm Crbn Fbr Rod 600-mm/MRConditional | |
| 394.92 | Lrg Ex-Fix 11-mm Crbn Fiber Rod 650-mm/MRConditional | |
| 390.041 | Small Ex-Fix Combination Clamp MR Conditional | |
| 395.680 | Small Ex-Fix 4-mm Curved Crbn Fiber Rod 60°/MRConditional | |
| 395.681 | Small Ex-Fix 4.0-mm Curved Crbn Fiber Rod 90°/MRConditional | |
| 395.682 | Small Ex-Fix 4.0mm Curved Crbn Fiber Rod-120°/MRConditional | |
| 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, MRConditional | |
| 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, MRConditional | |
| 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 ReprocessedSynthes External Fixation Devices are substantially equivalent to the predicate device |
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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.
§ 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.