(123 days)
Not Found (The 510(k) numbers are not listed)
Not Found
No
The summary describes a mechanical fixation device and its mechanical testing, with no mention of AI or ML.
Yes
The device is described as "used to secure soft tissue graft fixations during cruciate ligament reconstruction surgeries" and "to attach soft tissue allografts or autografts to host bone," indicating it directly supports or restores a bodily function during a surgical procedure.
No
The device is a fixation fastener used in surgery, not a tool for diagnosis. Its purpose is to secure soft tissue grafts, not to identify or determine the presence of a medical condition.
No
The device description explicitly states it is a "partially threaded metal fixation fastener," which is a physical hardware component, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "secure soft tissue graft fixations during cruciate ligament reconstruction surgeries." This is a surgical procedure performed in vivo (within the living body).
- Device Description: The device is a "partially threaded metal fixation fastener used to attach soft tissue allografts or autografts to host bone." This describes a surgical implant, not a device used to examine specimens in vitro (outside the living body).
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device is clearly intended for direct surgical use within a patient's body.
N/A
Intended Use / Indications for Use
The MedicineLodge, Inc. (MLI) - Cross Pin is used to secure soft tissue graft fixations during cruciate ligament reconstruction surgeries.
Product codes (comma separated list FDA assigned to the subject device)
87 JDW
Device Description
The MedicineLodge, Inc. (MLI) Cross Pin is a partially threaded metal fixation fastener used to attach soft tissue allografts or autografts to host bone.
To begin, the device is similar in design to currently marketed threaded fixation pins. The spiral threads (per ISO 5835) on the proximal one-third of the screw are designed to firmly grasp the host bone during insertion. The distal two-thirds of the MLI Cross Pin possesses two design characteristics common to cross pin devices.
a. Unthreaded Distal Two-thirds; The absence of threads along this portion of the cross pin allows the passage of the soft tissue graft around the screw.
b. Tapered Distal Two-thirds; The taper of the cross pin along the distal two-thirds allow for easy passage and positioning of this portion of the device through the tibio-femoral tunnel.
The MLI Cross Pin head conforms to ISO 5835 and the device is designed to be manually inserted using a standard cannulated 3.5mm (cannulation of 0.046") hex driver, per ASTM F-116-85.
The MLI Cross Pin will be provided with a 6.5mm outer diameter (Per ISO 5835) offered in lengths of 40mm, 50mm, 60mm and 70mm lengths. Table below lists the various MLI Cross Pin combinations along with corresponding part numbers.
All MLI Cross Pins will be manufactured from Ti-6A1-4V ELI material (ASTM F-136) and are anodized per AMS 2488C for a smoother and more uniform surface finish. The anodized layer additionally provides an inert coating which helps to prevent galling and corrosion by providing a passive surface.
As mentioned previously, the MLI Cross Pin possesses a central cannulation to allow the use of guide wires for accurate placement of the device in the host bone. In application, the use of guide wires reduces the chances of tunnel screw divergence. All MLI Cross Pins are designed for use with a 0.042 inch diameter guide wire, which is also provided by MedicineLodge, Inc. All instrumentation designed for use with the MLI Cross Pin is defined in Section 6, with engineering drawings presented in Appendix B.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue graft fixations during cruciate ligament reconstruction surgeries
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)
MedicineLodge, Inc. has conducted mechanical testing on the subject and a predicate device (DePuy Cross Pin; DePuy, Inc., Warsaw, IN) to prove substantial equivalence. The following mechanical tests were performed.
a. Static bending properties of the DePuy Cross Pin in a 3-point bending situation.
b. Static bending properties of the MLI Cross Pins in a 3-point bending situation.
MedicineLodge, Inc. conducted bending property studies on the subject and predicate device in a non-in-vitro mode to determine the effect of using a load on the cross pin to simulate the load applied on the cross pin via a graft.
Students t-test were done to determine any statistical differences or similarities between the two types of cross pin ligament fixation devices.
In comparing the load to failure between the two cross pin designs, we find no significant differences (p > 0.05).
Based on the mechanical testing conducted by MedicineLodge, Inc. on the subject and predicate device, conclusions can be drawn regarding the design difference between the subject and predicate device. The design differences seen in the subject device offer no inherent weakness and have functioned similar to the predicate device often showing potential for improved performance.
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.
Not Found (The 510(k) numbers are not listed)
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
§ 888.3040 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/0 description: The image shows the letters SEP, the number 17, and two solid black rectangles. The letters and numbers are also in black. The image is simple and contains only a few elements.
OF SAFETY AND 13. 210 SUMMARY EFFECTIVENESS (K) INFORMATION
- 13.1 Date of Summary Preparation May 15, 1996
- Manufactures Contact Person 13.2
Wade Fallin Vice President of Research and Development/General Manager 152 South 600 West Logan, UT 84321 Telephone: 801-753-7675 Fax: 801-753-7698
- 13.3 Proprietary Device Name MLI - Cross Pin
- 13.4 Common Name Threaded Fixation Pin
- 13.5 Classification Name Smooth or Threaded Metallic Bone Fixation Fastener
- 13.6 Classification Reference 21CFR 888.3040
- 13.7 Device Product Code 87 JDW
- 13.8 Regulatory Class Class II
- 13.9 Special Controls
At this time, the Food and Drug Administration generated performance standards applicable to the MLI - Cross Pin are not in force.
13.10 Materials
The following material is used in the manufacturing of the MLI - Cross Pin (All Sizes). Ti-6Al-4V ELI per ASTM F-136.
13.11 Indications for Use
The MedicineLodge, Inc. (MLI) - Cross Pin is used to secure soft tissue graft fixations during cruciate ligament reconstruction surgeries.
1
13.12 Device Description
The MedicineLodge, Inc. (MLI) Cross Pin is a partially threaded metal fixation fastener used to attach soft tissue allografts or autografts to host bone.
To begin, the device is similar in design to currently marketed threaded fixation pins. The spiral threads (per ISO 5835) on the proximal one-third of the screw are designed to firmly grasp the host bone during insertion. The distal two-thirds of the MLI Cross Pin possesses two design characteristics common to cross pin devices.
- Unthreaded Distal Two-thirds; The absence of threads along this portion of the a. cross pin allows the passage of the soft tissue graft around the screw.
- b. Tapered Distal Two-thirds; The taper of the cross pin along the distal two-thirds allow for easy passage and positioning of this portion of the device through the tibio-femoral tunnel.
The MLI Cross Pin head conforms to ISO 5835 and the device is designed to be manually inserted using a standard cannulated 3.5mm (cannulation of 0.046") hex driver, per ASTM F-116-85.
The MLI Cross Pin will be provided with a 6.5mm outer diameter (Per ISO 5835) offered in lengths of 40mm, 50mm, 60mm and 70mm lengths. Table below lists the various MLI Cross Pin combinations along with corresponding part numbers.
All MLI Cross Pins will be manufactured from Ti-6A1-4V ELI material (ASTM F-136) and are anodized per AMS 2488C for a smoother and more uniform surface finish. The anodized layer additionally provides an inert coating which helps to prevent galling and corrosion by providing a passive surface.
As mentioned previously, the MLI Cross Pin possesses a central cannulation to allow the use of guide wires for accurate placement of the device in the host bone. In application, the use of guide wires reduces the chances of tunnel screw divergence. All MLI Cross Pins are designed for use with a 0.042 inch diameter guide wire, which is also provided by MedicineLodge, Inc. All instrumentation designed for use with the MLI Cross Pin is defined in Section 6, with engineering drawings presented in Appendix B.
| PART #
STERILE | PART #
NON-STERILE | DIAMETER
(MM) | LENGTH
(MM) | DESCRIPTION | | |
|-------------------|-----------------------|------------------|----------------|---------------------------|--|--|
| 706540 | 716540 | 6.5mm | 40mm | 6.5mm x 40mm
Cross Pin | | |
| 706550 | 716550 | 6.5mm | 50mm | 6.5mm x 50mm
Cross Pin | | |
| 706560 | 716560 | 6.5mm | 60mm | 6.5mm x 60mm
Cross Pin | | |
| 706570 | 710570 | 6.5mm | 70mm | 6.5mm x 70mm
Cross Pin | | |
MLI- Cross Pin Sizes
2
| No. | MANUFACTURE'S NAME | DEVICE NAME | 510 (K)
APPROVED |
|-----|-----------------------------|---------------------------------|---------------------|
| 1. | DePuy, Inc.
Warsaw, IN | DePuy Cross Pin Screw
System | Yes |
| 2. | Arthrex, Inc.
Naples, FL | Arthrex Cross Pin | Yes |
Predicate Device Description
Substantial Equivalence Comparison 13.14
The following table displays the similarities and differences of the new device to the legally marketed devices to which equivalency is claimed. The materials, method of manufacture, method of sterilization and device packaging are identical to the predicate devices.
| No. | FEATURE | MLI - CROSS PIN | DEPUY CROSS PIN |
|---|---|---|---|
| 1. | Intended Use | Cruciate Ligament | |
| Reconstruction Surgery | Cruciate Ligament Reconstruction | ||
| Surgery | |||
| 2. | Diameter | 6.5mm | 4.5mm |
| 3. | Lengths | 40mm, 50mm, 60mm and | |
| 70mm | 40mm 45mm, 50mm, 55mm, | ||
| 60mm, 65mm and 70mm | |||
| 4. | Material | Ti-6Al-4V ELI per | |
| ASTM F-136 | 316 LVM SS | ||
| 5. | Method of insertion | 3.5mm Hex | 4.0mm Hex |
| 6. | Method of fixation to | ||
| bone | Screw Threads | Screw Threads | |
| 7. | Self tapping feature | Yes | Yes |
| 8. | Method of graft | ||
| attachment | Loop soft tissue around | ||
| implant | Loop soft tissue around implant or | ||
| drill hole through bone end of | |||
| graft | |||
| 9. | Cannulation for guide | ||
| wire | .046 cannulation for use of | ||
| .042 guide wire | None | ||
| 10. | Surface finish | Ti anodized | High polish |
| 11. | Thread crest | Soft | Soft |
| 12. | Packaging | Sterile and Non-Sterile | Sterile and Non-Sterile |
Direct Comparison to Already Marketed Products
3
Performance Testing (Subject and Predicate Devices) 13.15
MedicineLodge, Inc. has conducted mechanical testing on the subject and a predicate device (DePuy Cross Pin; DePuy, Inc., Warsaw, IN) to prove substantial equivalence. The following mechanical tests were performed.
- Static bending properties of the DePuy Cross Pin in a 3-point bending situation. a.
- Static bending properties of the MLI Cross Pins in a 3-point bending situation. b.
MedicineLodge, Inc. conducted bending property studies on the subject and predicate device in a non-in-vitro mode to determine the effect of using a load on the cross pin to simulate the load applied on the cross pin via a graft.
Students t-test were done to determine any statistical differences or similarities between the two types of cross pin ligament fixation devices.
In comparing the load to failure between the two cross pin designs, we find no significant differences (p > 0.05).
Based on the mechanical testing conducted by MedicineLodge, Inc. on the subject and predicate device, conclusions can be drawn regarding the design difference between the subject and predicate device. The design differences seen in the subject device offer no inherent weakness and have functioned similar to the predicate device often showing potential for improved performance. MedicineLodge, Inc. would like to claim substantial equivalence to the DePuy Cross Pin which is commercially available in the U.S. market.
13.16 Differences from Predicate Devices
The following enumerates the differences in design between the MLI - Cross Pin in comparison with a selected predicate device.
- Material: The MLI Cross Pin is manufactured from Ti-6Al-4V ELI per ASTM a. F-136 where as the DePuy Cross Pin is manufactured from 316 LVM stainless steel per ASTM A-479/A-479M.
- Cannulated vs. Non-cannulated: The MLI Cross Pin design allows for the use of b. a .042" guide wire to help position the cross pin in the tunnel. The DePuy Cross Pin features no such cannulation.
- 6.5mm vs 4.5mm thread form: The MLI Cross Pin thread form is that of a 6.5 C. HB (ISO 5835). The DePuy Cross Pin thread form is that of 4.5 HB (ISO 5835).
- Screw head vs no head: The MLI Cross Pin has a screw head (ISO 5835) to d. accommodate a standard 3.5mm hex to accommodate a hex driver (ASTM F-136). The DePuy Cross Pin has no defined screw head but has a hex nut used in conjunction with a hex driver socket.
13.17 Conclusion
Based on the design concept, use of standard material, feature comparisons to selected predicate devices, the device and predicate device testing, MedicineLodge, Inc. believes that sufficient evidence exists to conclude that the MLI - Cross Pin is substantially equivalent to existing legally marketed endosteal cruciate fixation devices.