(58 days)
No
The 510(k) summary describes reprocessed external fixation devices and their mechanical performance testing. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is an external fixation system intended to provide stabilization for fractures and other orthopedic conditions, which is a therapeutic function.
No
The device is an external fixation system used for stabilization of fractures and other orthopedic procedures; it does not diagnose medical conditions.
No
The device description explicitly states it includes "various rods and clamps/connectors" which are physical hardware components. The performance studies also focus on the structural integrity and functional performance of these physical components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as external fixation frame components used for stabilizing bone fractures, osteotomies, arthrodesis, and other orthopedic procedures. This is a mechanical function performed on the patient's body.
- Device Description: The description reinforces that the devices are assembled external to the operative or injury focus and will not be in direct patient contact. This further indicates a mechanical, external function.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status based on in vitro analysis
- Using reagents or assays
The device is a medical device used for structural support and stabilization of the musculoskeletal system, not for diagnostic testing performed outside the body.
N/A
Intended Use / Indications for Use
The Medline ReNewal Reprocessed Stryker External Fixation Devices are external fixation frame components for use with components of the Hoffmann 3 MR Conditional. Hoffmann II MR Conditional. Hoffmann II Compact MR Conditional and Hoffmann II Compact external fixation systems. They are intended to provide stabilization of open and/or unstable fractures and where the soft tissue injury may preclude the use of other fracture treatments such as IM rods, casts or other mean of internal fixations for use of external fixation devices include:
- · bone fracture fixation;
- · osteotomy:
- · arthrodesis:
- · correction of deformity; revision procedure where other treatments or devices have been unsuccessful; and
- · bone reconstruction procedures.
Product codes (comma separated list FDA assigned to the subject device)
JEC, LXT, KTT
Device Description
The Medline ReNewal Reprocessed Stryker External Fixation Devices are intended to provide temporary stabilization of open and/or unstable fractures where soft tissue injury may preclude the use of other fracture treatments. Additionally, the devices may be used for elective orthopedic interventions such as limb lengthening. Devices in the scope of this document include various rods and clamps/connectors that are assembled external to the operative or injury focus and will not be in direct patient contact.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 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:
◦ simulated use and artificial soiling; and
◦ structural integrity;
◦ carbon rod stiffness per the 4-point bend test (pre-conditioning);
◦ cyclical axial compression and tension bending test;
◦ carbon rod stiffness per the 4-point bend test (post conditioning); and
◦ disassembly and reassembly (pre-and post-sterilization).
• Cleaning:
◦ visual inspection;
◦ cleaning efficacy (residual protein and residual carbohydrate).
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
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, with three overlapping profiles suggesting a sense of community and support. The profiles are rendered in a dark color, creating a strong contrast against the white background. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 28, 2016
Surgical Instrument Service and Savings Inc. Brandi J. Panteleon Director, Quality Assurance and Regulatory Affairs 2747 SW 6th St. Redmond, Oregon 97756
Re: K163028
Trade/Device Name: Medline ReNewal Reprocessed Stryker External Fixation Devices Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: JEC Dated: October 28, 2016 Received: October 31, 2016
Dear Brandi Panteleon:
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Caroline Rhim -S
for
Mark Melkerson Division Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure: Reprocessed List
2
Part Number | Description | ||
---|---|---|---|
4920-1-010 | Rod to Rod Coupling for 8mm rods or posts | ||
4920-1-020 | Pin to Rod Coupling for 4-5mm pins/8mm rods or posts | ||
4920-1-030 | Inverted Pin to Rod Coupling for 8mm rods or posts/4-5mm pins | ||
4920-1-100 | Tube to Rod Coupling for 20mm tubes/8mm rods or posts | ||
4920-2-020 | 5 Hole Pin Clamp for 4/5/6mm pins | ||
4920-2-060 | 10-Hole Pin Clamp for 4/5/6mm pins | ||
4920-2-080 | Pelvic Clamp for 4/5/6mm pins | ||
4920-2-120 | Straight Post 8mm | ||
4920-2-140 | 30° Angled Post 8mm | ||
4920-2-160 | 90° Angled Post 8mm | ||
4920-2-181 | HII THREADED POST W 13mm NUT | ||
4920-9-020 | Removable Thumbwheel | ||
4940-1-010 | Rod to Rod Coupling for Ø5mm rods or posts | ||
4940-1-015 | HII Compact Baltimore Coupling | ||
4940-1-020 | Pin to Rod Coupling- Ø5mm rods or posts/Ø3-4mm pins | ||
4940-1-058 | Rod to Rod Coupling-Ø8mm rods, posts/Ø5mm rods, posts | ||
4940-1-100 | Tube to Rod Coupling - Ø15mm tube/Ø5mm rods or posts | ||
4940-2-020 | Hoffmann 2 Compact Pin Clamp 4 hole Pin Clamp-Ø3 and Ø4mm pins | ||
4940-2-120 | Straight Post Ø5mm | ||
4940-2-140 | 30° Angled Post Ø5mm | ||
4940-2-200 | Peri-Articular Pin Clamp for Ø3mm pins | ||
4960-1-010 | Micro Rod to Rod Coupling 3mm/3mm | ||
4960-1-020 | Micro Pin to Rod Coupling 1.65mm-2mm/3mm | ||
4960-1-060 | Micro Rod to Rod Coupling 5mm/3mm | ||
4960-2-020 | Micro Multi-Pin Clamp | ||
4960-2-030 | 90° Micro Multi-Pin Clamp | ||
4960-3-020 | HII Micro Lengthener Pin Clamp | ||
4960-3-030 | HII Micro Lengthener Thumbwheel | ||
5029-1-611 | Ball Joint 5 Hole Double Parallel | ||
5029-8-805 | Carbon Connecting Rod 8mm x 65mm | ||
5029-8-810 | Carbon Connecting Rod 8mm x 100mm | ||
5029-8-815 | Carbon Connecting Rod 8mm x 150mm | ||
5029-8-820 | Carbon Connecting Rod 8mm x 200mm | ||
5029-8-825 | Carbon Connecting Rod 8mm x 250mm | ||
5029-8-830 | Carbon Connecting Rod 8mm x 300mm | ||
5029-8-835 | Carbon Connecting Rod 8mm x 350mm | ||
5029-8-840 | Carbon Connecting Rod 8mm x 400mm | ||
5029-8-845 | Carbon Connecting Rod 8mm x 450mm | ||
5029-8-850 | Carbon Connecting Rod 8mm x 500mm | ||
5049-5-065 | Stainless Steel Connecting Rod Ø5mm x 65mm | ||
5049-5-100 | Stainless Steel Connecting Rod Ø5mm x 100mm | ||
5049-5-150 | Stainless Steel Connecting Rod Ø5mm x 150mm | ||
5049-5-200 | Stainless Steel Connecting Rod Ø5mm x 200mm | ||
5049-5-250 | Stainless Steel Connecting Rod Ø5mm x 250mm | ||
5049-5-300 | Stainless Steel Connecting Rod Ø5mm x 300mm | ||
5049-5-505 | Carbon Connecting Rod Ø5mm x 65mm | ||
5049-5-510 | Carbon Connecting Rod Ø5mm x 100mm | ||
5049-5-515 | Carbon Connecting Rod Ø5mm x 150mm | ||
5049-5-520 | Carbon Connecting Rod Ø5mm x 200mm | ||
5049-5-525 | Carbon Connecting Rod Ø5mm x 250mm | ||
5049-5-530 | Carbon Connecting Rod Ø5mm x 300mm | ||
5049-7-018 | Semi Circular Curved Rod-Stainless Steel Ø5mm x 111mm | ||
5049-7-020 | Semi Circular Curved Rod-Stainless Steel Ø5mm x 146mm | ||
5079-5-030 | Stainless Steel Connecting Rod 3mm x 30mm | ||
5079-5-040 | Stainless Steel Connecting Rod 3mm x 40mm | ||
5079-5-050 | Stainless Steel Connecting Rod 3mm x 50mm | ||
5079-5-060 | Stainless Steel Connecting Rod 3mm x 600mm | ||
5079-5-070 | Connecting Rod 3mm x 70mm | ||
5079-5-090 | 5079-5-120 | Stainless Steel Connecting Rod 3mm x 90mm | Stainless Steel Connecting Rod 3mm x 120mm |
5079-5-150 | Stainless Steel Connecting Rod 3mm x 150mm | ||
5079-5-180 | Connecting Rod 3mm x 180mm | ||
5079-5-250 | Connecting Rod 3mm x 250mm | ||
5079-5-300 | Connecting Rod 3mm x 300mm | ||
5079-6-030 | Carbon Connecting Rod 3mm x 30mm | ||
5079-6-040 | Carbon Connecting Rod 3mm x 40mm | ||
5079-6-050 | Carbon Connecting Rod 3mm x 50mm | ||
5079-6-060 | Carbon Connecting Rod 3mm x 60mm | ||
5079-6-090 | Carbon Connecting Rod 3mm x 90mm | ||
5079-6-120 | Carbon Connecting Rod 3mm x 120mm | ||
5079-6-150 | Carbon Connecting Rod 3mm x 150mm |
3
Part Number | Description |
---|---|
4921-1-010 | MR conditional 8mm Rods or Posts, Rod to Rod Coupling (Gold Hardware) |
4921-1-020 | MR conditional Pin to Rod Coupling for Ø4-5mm pins/Ø8mm rods or posts (Gold Hardware) |
4921-1-030 | MR conditional Inverted Pin to Rod Coupling for Ø8mm rods or posts/Ø4-5mm pins (Gold Hardware) |
4921-1-100 | MR conditional Tube to Rod Coupling for Ø20mm tubes/Ø8mm rods or posts (Gold Hardware) |
4921-2-020 | MR conditional 5-Hole Pin Clamp for Ø4, Ø5, and Ø6mm pins (Gold Hardware) |
4921-2-060 | MR conditional 10-Hole Pin Clamp for Ø4, Ø5, and Ø6mm pins (Gold Hardware) |
4921-2-080 | MR conditional Pelvic Clamp for Ø4, Ø5, and Ø6mm pins (Gold Hardware) |
4921-2-120 | MR conditional Straight Post Ø8mm (Gold Tip) |
4921-2-140 | MR conditional 30° Angled Post Ø8mm (Gold Tip) |
4941-1-010 | MR conditional rod to Rod Coupling for Ø5mm rods or posts |
4941-1-020 | MR conditional Pin to Rod Coupling for Ø5mm rods or posts/Ø3-4mm pins |
4941-1-058 | MR conditional Rod to Rod Coupling for Ø8mm rods or posts/Ø5mm rods or posts |
4941-1-100 | MR conditional Tube to Rod Coupling for Ø15mm tube/Ø5mm rods or posts |
4941-2-120 | MR conditional 30° Angled Post Ø5mm |
4941-2-140 | MR conditional 4941-2-140 30° Angled Post Ø5mm |
4941-2-200 | MR conditional Peri-Articular Pin Clamp for Ø3mm pins |
5028-7-030 | MR conditional Semi-Circular Carbon Rod 174mm (L) |
5028-8-065 | MR conditional Carbon Connecting Rod 65mm Ø8mm (Yellow) |
5028-8-100 | MR conditional Carbon Connecting Rod 100mm Ø8mm (Yellow) |
5028-8-150 | MR conditional Carbon Connecting Rod 150mm Ø8mm (Yellow) |
5028-8-200 | MR conditional Carbon Connecting Rod 200mm Ø8mm (Yellow) |
5028-8-250 | MR conditional Carbon Connecting Rod 250mm Ø8mm (Yellow) |
5028-8-300 | MR conditional Carbon Connecting Rod 300mm Ø8mm (Yellow) |
5028-8-350 | MR conditional Carbon Connecting Rod 350mm Ø8mm (Yellow) |
5028-8-400 | MR conditional Carbon Connecting Rod 400mm Ø8mm (Yellow) |
5028-8-450 | MR conditional Carbon Connecting Rod 450mm Ø8mm (Yellow) |
5028-8-500 | MR conditional Carbon Connecting Rod 500mm Ø8mm (Yellow) |
5048-5-065 | MR conditional Carbon Connecting Rod 65mm Ø5mm (Yellow) |
5048-5-100 | MR conditional Carbon Connecting Rod 100mm Ø5mm (Yellow) |
5048-5-150 | MR conditional Carbon Connecting Rod 150mm Ø5mm (Yellow) |
5048-5-200 | MR conditional Carbon Connecting Rod 200mm Ø5mm (Yellow) |
5048-5-250 | MR conditional Carbon Connecting Rod 250mm Ø5mm (Yellow) |
5048-5-300 | MR conditional Carbon Connecting Rod 300mm Ø5mm (Yellow) |
4921-2-020 | AHS MR conditional 5 HOLE PIN CLAMP |
4921-2-160 | MR conditional 90 DEGREE POST |
4941-2-020 | 4 hole pin clamp for Ø3 and Ø4mm pins |
Hoffmann III MR Conditional (1.5 T) | |
Part Number | Description |
4922-1-010 | Delta Coupling, Rod-to-Rod or Pin-to-Rod, Ø5/8/11mm Rods and Ø5mm Apex Pins |
4922-1-020 | Delta Coupling, Pin-to-Rod, Ø5/8/11mm Rods and Ø4/5/6mm Apex Pins |
4922-1-030 | Delta Coupling, Pin-to-Rod, inverted, Ø5/8/11mm Rods and Ø4/5/6mm Apex Pins |
4922-2-020 | 5-Hole Pin Clamp |
4922-2-120 | Straight Post Ø11mm |
4922-2-140 | 30° Angled Post Ø11mm |
4922-2-160 | 90° Angled Post Ø11mm |
4922-2-220 | 5-Hole Pin Clamp with two Ø11mm Straight Posts |
4922-2-240 | 5-Hole Pin Clamp with two Ø11mm 30° Angled Posts |
4922-2-320 | 5-Hole Pin Clamp with one Ø11mm Straight Post |
4922-2-340 | 5-Hole Pin Clamp with one Ø11mm 30° Angled Post |
4922-8-100 | Ø11mm Vectran coated Carbon Connecting Rods 100mm |
4922-8-150 | Ø11mm Vectran coated Carbon Connecting Rods 150mm |
4922-8-200 | Ø11mm Vectran coated Carbon Connecting Rods 200mm |
4922-8-250 | Ø11mm Vectran coated Carbon Connecting Rods 250mm |
4922-8-300 | Ø11mm Vectran coated Carbon Connecting Rods 300mm |
4922-8-350 | Ø11mm Vectran coated Carbon Connecting Rods 350mm |
4922-8-400 | Ø11mm Vectran coated Carbon Connecting Rods 400mm |
4922-8-450 | Ø11mm Vectran coated Carbon Connecting Rods 450mm |
4922-8-500 | Ø11mm Vectran coated Carbon Connecting Rods 500mm |
4922-8-550 | Ø11mm Vectran coated Carbon Connecting Rods 550mm |
4922-8-600 | Ø11mm Vectran coated Carbon Connecting Rods 600mm |
4922-8-650 | Ø11mm Vectran coated Carbon Connecting Rods 650mm |
4
5
Indications for Use
Device Name
Medline ReNewal Reprocessed Stryker External Fixation Devices
Indications for Use (Describe)
The Medline ReNewal Reprocessed Stryker External Fixation Devices are external fixation frame components for use with components of the Hoffmann 3 MR Conditional. Hoffmann II MR Conditional. Hoffmann II Compact MR Conditional and Hoffmann II Compact external fixation systems. They are intended to provide stabilization of open and/or unstable fractures and where the soft tissue injury may preclude the use of other fracture treatments such as IM rods, casts or other mean of internal fixations for use of external fixation devices include:
- · bone fracture fixation;
- · osteotomy:
- · arthrodesis:
- · correction of deformity; revision procedure where other treatments or devices have been unsuccessful; and
- · bone reconstruction procedures.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
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6
Image /page/6/Picture/1 description: The image shows the logo for Medline Renewal. The Medline logo is on the left, and it features the word "MEDLINE" in blue, with a blue star-like symbol below it. To the right of the Medline logo is the word "Renewal" in large, bold letters, with "Re" in green and "newal" in blue. Below "Renewal" is the phrase "Full Circle Reprocessing" in a smaller, lighter font.
510(k) Summary K163028
| Submitter/
Owner | Surgical Instrument Service and Saving Inc. dba Medline ReNewal
2747 SW 6th St.
Redmond, OR 97756 | |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|
| Contact Name | Brandi Panteleon
Director, Quality Assurance and Regulatory Affairs
P: 541-516-4180
F: 541-923-3375
E: bpanteleon@medline.com | |
| Prepared by | Stephanie Boyle Mays
Regulatory Affairs Specialist, Regulatory Affairs
P: 541-516-4205
F: 541-923-3375
E:smays@medline.com | |
| Date Prepared | October 28, 2016 | |
| Device Names | Proprietary Name: Medline ReNewal Reprocessed Stryker External
Fixation Devices
Common Name: External Fixation Devices, Fixation Appliance,
single/multiple component (component) | |
| 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/JEC (subsequent code LXT);
888.3040/JEC; and 888.3030/KTT | |
| Predicate
Device | K102885 Stryker Hoffman II External Fixation System Line Extension Model
4920-1-010, 4920-1-020; 4920-1-030, 4920-1-100, Hoffmann II EX | |
| Reference
Device 1 | K952730 Howmedica Hoffmann II External Fixation System | |
| Reference
Device 2 | K122284 Stryker Hoffmann 3 Modular External Fixation System | |
| Device
Description | The Medline ReNewal Reprocessed Stryker External Fixation Devices are
intended to provide temporary stabilization of open and/or unstable
fractures where soft tissue injury may preclude the use of other fracture
treatments. Additionally, the devices may be used for elective orthopedic
interventions such as limb lengthening. Devices in the scope of this
document include various rods and clamps/connectors that are assembled
external to the operative or injury focus and will not be in direct patient
contact. | |
| Statement of
Intended Use | The Medline ReNewal Reprocessed Stryker External Fixation Devices are
components in an external fixation system that is used to provide
stabilization of open and/or unstable fractures and where soft tissue injury
may preclude the use of other fracture treatments such as IM rods, casts or
other means of fixation. | |
| Indications | The Medline ReNewal Reprocessed Stryker External Fixation Devices are external fixation frame components for use with components of the Hoffman 3 MR Conditional, Hoffmann II MR Conditional, Hoffmann II, Hoffmann II Compact MR Conditional and Hoffmann II Compact external fixation systems. They are intended to provide stabilization of open and/or unstable fractures and where the soft tissue injury may preclude the use of other fracture treatments such as IM rods, casts or other mean of internal fixation The indications for use of external fixation devices include:
• bone fracture fixation;
• osteotomy;
• arthrodesis;
• correction of deformity; revision procedure where other treatments or devices have been unsuccessful; and
• bone reconstruction procedures. | |
| Technological
Characteristics | The Medline ReNewal Reprocessed Stryker External Fixation 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:
◦ simulated use and artificial soiling; and
◦ structural integrity;
◦ carbon rod stiffness per the 4-point bend test (pre-conditioning);
◦ cyclical axial compression and tension bending test;
◦ carbon rod stiffness per the 4-point bend test (post conditioning); and
◦ disassembly and reassembly (pre-and post-sterilization).
• Cleaning:
◦ visual inspection;
◦ cleaning efficacy (residual protein and residual carbohydrate). | |
| | OEM
Model | Description |
| | Hoffmann II | |
| Device Models | 4920-1-010 | Rod to Rod Coupling for 8mm rods or posts |
| | 4920-1-020 | Pin to Rod Coupling for 4-5mm pins/8mm rods or posts |
| | 4920-1-030 | Inverted Pin to Rod Coupling for 8mm rods or posts/4-5mm pins |
| | 4920-1-100 | Tube to Rod Coupling for 20mm tubes/8mm rods or posts |
| | 4920-2-020 | 5 Hole Pin Clamp for 4/5/6mm pins |
| | 4920-2-060 | 10-Hole Pin Clamp for 4/5/6mm pins |
| | 4920-2-080 | Pelvic Clamp for 4/5/6mm pins |
| | 4920-2-120 | Straight Post 8mm |
| | 4920-2-140 | 30° Angled Post 8mm |
| OEM
Model | Description | |
| Hoffman II continued | | |
| 4920-2-181 | HII THREADED POST W 13mm NUT | |
| 4920-9-020 | Removable Thumbwheel | |
| 4940-1-010 | Rod to Rod Coupling for Ø5mm rods or posts | |
| 4940-1-015 | HII Compact Baltimore Coupling | |
| 4940-1-020 | Pin to Rod Coupling- Ø5mm rods or posts/Ø3-4mm pins | |
| 4940-1-058 | Rod to Rod Coupling-Ø8mm rods, posts/Ø5mm rods, posts | |
| 4940-1-100 | Tube to Rod Coupling - Ø15mm tube/Ø5mm rods or posts | |
| 4940-2-020 | Hoffmann 2 Compact Pin Clamp 4 hole Pin Clamp-Ø3 and
Ø4mm pins | |
| 4940-2-120 | Straight Post Ø5mm | |
| 4940-2-140 | 30° Angled Post Ø5mm | |
| 4940-2-200 | Peri-Articular Pin Clamp for Ø3mm pins | |
| 4960-1-010 | Micro Rod to Rod Coupling 3mm/3mm | |
| 4960-1-020 | Micro Pin to Rod Coupling 1.65mm-2mm/3mm | |
| 4960-1-060 | Micro Rod to Rod Coupling 5mm/3mm | |
| 4960-2-020 | Micro Multi-Pin Clamp | |
| 4960-2-030 | 90° Micro Multi-Pin Clamp | |
| 4960-3-020 | HII Micro Lengthener Pin Clamp | |
| 4960-3-030 | HII Micro Lengthener Thumbwheel | |
| 5029-1-611 | Ball Joint 5 Hole Double Parallel | |
| 5029-8-805 | Carbon Connecting Rod 8mm x 65mm | |
| 5029-8-810 | Carbon Connecting Rod 8mm x 100mm | |
| 5029-8-815 | Carbon Connecting Rod 8mm x 150mm | |
| 5029-8-820 | Carbon Connecting Rod 8mm x 200mm | |
| 5029-8-825 | Carbon Connecting Rod 8mm x 250mm | |
| 5029-8-830 | Carbon Connecting Rod 8mm x 300mm | |
| 5029-8-835 | Carbon Connecting Rod 8mm x 350mm | |
| 5029-8-840 | Carbon Connecting Rod 8mm x 400mm | |
| 5029-8-845 | Carbon Connecting Rod 8mm x 450mm | |
| 5029-8-850 | Carbon Connecting Rod 8mm x 500mm | |
| 5049-5-065 | Stainless Steel Connecting Rod Ø5mm x 65mm | |
| 5049-5-100 | Stainless Steel Connecting Rod Ø5mm x 100mm | |
| 5049-5-150 | Stainless Steel Connecting Rod Ø5mm x 150mm | |
| 5049-5-200 | Stainless Steel Connecting Rod Ø5mm x 200mm | |
| 5049-5-250 | Stainless Steel Connecting Rod Ø5mm x 250mm | |
| 5049-5-300 | Stainless Steel Connecting Rod Ø5mm x 300mm | |
| 5049-5-505 | Carbon Connecting Rod Ø5mm x 65mm | |
| 5049-5-510 | Carbon Connecting Rod Ø5mm x 100mm | |
| 5049-5-515 | Carbon Connecting Rod Ø5mm x 150mm | |
| 5049-5-520 | Carbon Connecting Rod Ø5mm x 200mm | |
| 5049-5-525 | Carbon Connecting Rod Ø5mm x 250mm | |
| 5049-5-530 | Carbon Connecting Rod Ø5mm x 300mm | |
| 5049-7-018 | Semi Circular Curved Rod-Stainless Steel Ø5mm x 111mm | |
| OEM
Model | Description | |
| Hoffman II continued | | |
| 5079-5-030 | Stainless Steel Connecting Rod 3mm x 30mm | |
| 5079-5-040 | Stainless Steel Connecting Rod 3mm x 40mm | |
| 5079-5-050 | Stainless Steel Connecting Rod 3mm x 50mm | |
| 5079-5-060 | Stainless Steel Connecting Rod 3mm x 600mm | |
| 5079-5-070 | Connecting Rod 3mm x 70mm | |
| 5079-5-090 | Stainless Steel Connecting Rod 3mm x 90mm | |
| 5079-5-120 | Stainless Steel Connecting Rod 3mm x 120mm | |
| 5079-5-150 | Stainless Steel Connecting Rod 3mm x 150mm | |
| 5079-5-180 | Connecting Rod 3mm x 180mm | |
| 5079-5-250 | Connecting Rod 3mm x 250mm | |
| 5079-5-300 | Connecting Rod 3mm x 300mm | |
| 5079-6-030 | Carbon Connecting Rod 3mm x 30mm | |
| 5079-6-040 | Carbon Connecting Rod 3mm x 40mm | |
| 5079-6-050 | Carbon Connecting Rod 3mm x 50mm | |
| 5079-6-060 | Carbon Connecting Rod 3mm x 60mm | |
| 5079-6-090 | Carbon Connecting Rod 3mm x 90mm | |
| 5079-6-120 | Carbon Connecting Rod 3mm x 120mm | |
| 5079-6-150 | Carbon Connecting Rod 3mm x 150mm | |
| Hoffmann II MR Conditional (3.0 T) | | |
| 4921-1-010 | MR conditional 8mm Rods or Posts, Rod to Rod Coupling
(Gold Hardware) | |
| 4921-1-020 | MR conditional Pin to Rod Coupling for Ø4-5mm
pins/Ø8mm rods or posts (Gold Hardware) | |
| 4921-1-030 | MR conditional Inverted Pin to Rod Coupling for Ø8mm
rods or posts/Ø4-5mm pins (Gold Hardware) | |
| 4921-1-100 | MR conditional Tube to Rod Coupling for Ø20mm
tubes/Ø8mm rods or posts (Gold Hardware) | |
| 4921-2-020 | MR conditional 5-Hole Pin Clamp for Ø4, Ø5, and Ø6mm
pins (Gold Hardware) | |
| 4921-2-060 | MR conditional 10-Hole Pin Clamp for Ø4, Ø5, and Ø6mm
pins (Gold Hardware) | |
| 4921-2-080 | MR conditional Pelvic Clamp for Ø4, Ø5, and Ø6mm pins
(Gold Hardware) | |
| 4921-2-120 | MR conditional Straight Post Ø8mm (Gold Tip) | |
| 4921-2-140 | MR conditional 30° Angled Post Ø8mm (Gold Tip) | |
| 4941-1-010 | MR conditional rod to Rod Coupling for Ø5mm rods or
posts | |
| 4941-1-020 | MR conditional Pin to Rod Coupling for Ø5mm rods or
posts/Ø3-4mm pins | |
| 4941-1-058 | MR conditional Rod to Rod Coupling for Ø8mm rods or
posts/Ø5mm rods or posts | |
| 4941-1-100 | MR conditional Tube to Rod Coupling for Ø15mm
tube/Ø5mm rods or posts | |
| 4941-2-120 | MR conditional 30° Angled Post Ø5mm | |
| 4941-2-140 | MR conditional 4941-2-140 30° Angled Post Ø5mm | |
| 4941-2-200 | MR conditional Peri-Articular Pin Clamp for Ø3mm pins | |
| OEM
Model | Description | |
| Hoffmann II MR Conditional (3.0 T) | | |
| 5028-7-030 | MR conditional Semi-Circular Carbon Rod 174mm (L) | |
| 5028-8-065 | MR conditional Carbon Connecting Rod 65mm Ø8mm
(Yellow) | |
| 5028-8-100 | MR conditional Carbon Connecting Rod 100mm Ø8mm
(Yellow) | |
| 5028-8-150 | MR conditional Carbon Connecting Rod 150mm Ø8mm
(Yellow) | |
| 5028-8-200 | MR conditional Carbon Connecting Rod 200mm Ø8mm
(Yellow) | |
| 5028-8-250 | MR conditional Carbon Connecting Rod 250mm Ø8mm
(Yellow) | |
| 5028-8-300 | MR conditional Carbon Connecting Rod 300mm Ø8mm
(Yellow) | |
| 5028-8-350 | MR conditional Carbon Connecting Rod 350mm Ø8mm
(Yellow) | |
| 5028-8-400 | MR conditional Carbon Connecting Rod 400mm Ø8mm
(Yellow) | |
| 5028-8-450 | MR conditional Carbon Connecting Rod 450mm Ø8mm
(Yellow) | |
| 5028-8-500 | MR conditional Carbon Connecting Rod 500mm Ø8mm
(Yellow) | |
| 5048-5-065 | MR conditional Carbon Connecting Rod 65mm Ø5mm
(Yellow) | |
| 5048-5-100 | MR conditional Carbon Connecting Rod 100mm Ø5mm
(Yellow) | |
| 5048-5-150 | MR conditional Carbon Connecting Rod 150mm Ø5mm
(Yellow) | |
| 5048-5-200 | MR conditional Carbon Connecting Rod 200mm Ø5mm
(Yellow) | |
| 5048-5-250 | MR conditional Carbon Connecting Rod 250mm Ø5mm
(Yellow) | |
| 5048-5-300 | MR conditional Carbon Connecting Rod 300mm Ø5mm
(Yellow) | |
| 4921-2-
020AHS | MR conditional 5 HOLE PIN CLAMP | |
| 4921-2-160 | MR conditional 90 DEGREE POST | |
| 4941-2-020 | 4 hole pin clamp for Ø3 and Ø4mm pins | |
| Hoffman 3 MR conditional (1.5 T) | | |
| 4922-1-010 | Delta Coupling, Rod-to-Rod or Pin-to-Rod, Ø5/8/11mm
Rods and Ø5mm Apex Pins | |
| 4922-1-020 | Delta Coupling, Pin-to-Rod, Ø5/8/11mm Rods and
Ø4/5/6mm Apex Pins | |
| 4922-1-030 | Delta Coupling, Pin-to-Rod, inverted, Ø5/8/11mm Rods and
Ø4/5/6mm Apex Pins | |
| 4922-2-020 | 5-Hole Pin Clamp | |
| 4922-2-120 | Straight Post Ø11mm | |
| OEM Model | Description | |
| Hoffman III MR conditional (1.5 T) | | |
| 4922-2-140 | 30° Angled Post Ø11mm | |
| 4922-2-160 | 90° Angled Post Ø11mm | |
| 4922-2-220 | 5-Hole Pin Clamp with two Ø11mm Straight Posts | |
| 4922-2-240 | 5-Hole Pin Clamp with two Ø11mm 30o Angled Posts | |
| 4922-2-320 | 5-Hole Pin Clamp with one Ø11mm Straight Post | |
| 4922-2-340 | 5-Hole Pin Clamp with one Ø11mm 30o Angled Post | |
| 4922-8-100 | Ø11mm Vectran coated Carbon Connecting Rods 100mm | |
| 4922-8-150 | Ø11mm Vectran coated Carbon Connecting Rods 150mm | |
| 4922-8-200 | Ø11mm Vectran coated Carbon Connecting Rods 200mm | |
| 4922-8-250 | Ø11mm Vectran coated Carbon Connecting Rods 250mm | |
| 4922-8-300 | Ø11mm Vectran coated Carbon Connecting Rods 300mm | |
| 4922-8-350 | Ø11mm Vectran coated Carbon Connecting Rods 350mm | |
| 4922-8-400 | Ø11mm Vectran coated Carbon Connecting Rods 400mm | |
| 4922-8-450 | Ø11mm Vectran coated Carbon Connecting Rods 450mm | |
| 4922-8-500 | Ø11mm Vectran coated Carbon Connecting Rods 500mm | |
| 4922-8-550 | Ø11mm Vectran coated Carbon Connecting Rods 550mm | |
| 4922-8-600 | Ø11mm Vectran coated Carbon Connecting Rods 600mm | |
| 4922-8-650 | Ø11mm Vectran coated Carbon Connecting Rods 650mm | |
| a | OEM = original equipment manufacturer. | |
7
Image /page/7/Picture/1 description: The image shows the Medline Renewal logo. The Medline logo is on the left, and the Renewal logo is on the right. The Renewal logo is in green and blue, and the text "Full Circle Reprocessing" is below the Renewal logo.
90° Angled Post 8mm
4920-2-160
8
Image /page/8/Picture/1 description: The image contains the Medline Renewal logo. The Medline logo is on the left, and the Renewal logo is on the right. The Renewal logo is green and blue, and the text below it says "Full Circle Reprocessing".
Device Models continued
9
Image /page/9/Picture/1 description: The image shows the Medline Renewal logo. The Medline logo is on the left, and the Renewal logo is on the right. The Medline logo is a blue star with the word "MEDLINE" in blue letters next to it. The Renewal logo is in two colors, with "Re" in green and "Newal" in blue. Below Renewal, the words "Full Circle Reprocessing" are written in a smaller font.
10
Image /page/10/Picture/1 description: The image shows the Medline Renewal logo. The word "Medline" is in blue and is accompanied by a blue star-like symbol. To the right of the Medline logo is the word "Renewal" in green and blue, with "Re" in green and "newal" in blue. Below the word "Renewal" is the phrase "Full Circle Reprocessing" in a smaller font.
11
Image /page/11/Picture/1 description: The image contains 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 phrase "Full Circle Reprocessing" in a smaller font size and in blue. To the left of the word "Renewal" is the Medline logo, which consists of the word "MEDLINE" in blue with a stylized blue star below it.