(247 days)
No
The 510(k) summary describes a mechanical implant for joint replacement and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies are based on mechanical testing.
Yes
The device is described as "a hemi arthroplasty implant" and is intended for "treatment of patients with degenerative and post-traumatic arthritis," directly indicating its therapeutic purpose to treat a medical condition.
No
Explanation: The device is an implantable medical device designed for treating degenerative and post-traumatic arthritis in the first metatarsophalangeal joint, not for diagnosing conditions.
No
The device description clearly states it is a physical implant made of cobalt chrome alloy and titanium alloy, intended for surgical implantation. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes a surgical implant for treating arthritis in the first metatarsophalangeal joint. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a physical implant made of metal alloys designed to be surgically placed in the body. This is consistent with a medical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue), detect substances, or provide information about a patient's health status through in vitro analysis.
- Performance Studies: The performance studies described are mechanical tests evaluating the physical properties and durability of the implant, which are typical for surgical devices, not IVDs.
In summary, the device is a surgical implant intended for direct therapeutic use in the body, which falls under the category of a medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Hemi arthroplasty implant for first metatarsophalangeal joint for use in the treatment of patients with degenerative and post-traumatic arthritis in the first metatarsal joint in the presence of good bone stock along with the following clinical conditions; hallux valgus or hallux limitus, hallux rigidus, and an unstable or painful metatarsal/phalangeal (MTP) joint. The device is a single use implant intended to be used with bone cement.
Product codes
KWD
Device Description
The CAP™ Great Toe Resurfacinq Hemi-arthroplasty implant is a cobalt chrome alloy, 2-piece implant to supplement first metatarsal phalangeal joint arthroplasty. The implant is designed to provide a smooth surface for the first metatarsophalangeal joint as a the treatment of patients with degenerative and post-traumatic arthritis in the first metatarsal joint in the presence of good bone stock along with the following clinical conditions; hallux valqus or hallux limitus, hallux rigidus, and an unstable or painful metatarsal/phalangeal (MTP) joint. The device is a single use implant intended to be used with bone cement.
The CAP™ Great Toe Resurfacing Hemi-arthroplasty implant consists of two components, a taper post component and an articular component, that mate together via a taper interlock to provide stable and immobile fixation of the implant and stress bearing contact at the bone/prosthetic interface.
The first implant component is a Taper Post manufactured of a Ti-6AI-4V ELI alloy per ASTM F136. The Taper Post has a tapering distal tip, a full-length cannulation, and a proximal female taper bore.
The second implant is an articular component manufactured of a Cobalt-Chromium-Molybdenum alloy per ASTM F799 and ASTM F1537. The articular component has a bone contact surface that is coated with a CP Titanium coating and a polished articular bearing surface. For greater detail, refer to section 8.2 to view engineering drawings illustrating the various components.
Utilizing the drill guide provided within the CAP™ Great Toe Resurfacing Hemiarthroplasty implant instrumentation set, a surgeon is able to define a working axis that is normal to the articular cartilage surface at the site of the defect. After drilling a pilot hole, theTaper Post is screwed into place using the trial cap to ensure that the surface of the articular component will be tangent and congruent to the existing cartilage surface when seated. Using the contact probe instrument to the explant diameter, offset measurements are taken to define the topography of the patients surrounding articular surface by revolving the probe around a centering shaft coaxial to the working axis of the Taper Post. With these offset measurements, the surgeon is able to select the articular component (sized to match great toe metatarsal head) that will allow it to seat flush to the surrounding articular surface. Offset increments in .5mm sizes will allow for an optimal fit to the existing articular surface.
A reamer, which matches the articular component internal geometry is used to prepare the site for the prosthetic to be implanted. This allows for a precise fit of the implant to the prepared site and minimizes bone resection, so as to provide minimal impact to any future arthroplasty procedure. The articular component is then impacted to seat the taper interlock between the two components.
The prosthetic is intended to provide an effective means for treatment of patients with degenerative and post-traumatic arthritis, hallux valgus, hallux rigidus, hallux limitus, and/or an unstable or painful metatarsal/phalangeal (MTP) joint.
The device has been designed to offer a number of clinical benefits to the user and patient. The device is technically easy to implant, and offers the surgeon a high degree of precision and flexibility in sizing and fitting the articular component to the existing anatomy. A reduction in bone and articular cartilage resection is also offered over the predicate devices, providing a more physiologically normal joint in terms of load and impact distribution.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
first metatarsophalangeal joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon
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)
Mechanical test protocol has been completed using the proposed device including testing of the taper post component and the articular component per the guidelines established in CDRH Guidance Document for Testing Non-Articulating, Mechanically Locked, Modular Implant Components and ASTM F 1814 "Standard Guide for Evaluating Modular Hip and Knee Joint Components".
The following non-clinical tests were conducted to assess the device performance:
- Axial Assembly and Disassembly .
- Rigidity Characterization .
- Cyclic Fatigue Failure, Disassembly .
- Fretting, Fretting/ Corrosion (ASTM F897) .
- Resistance to Torque of Head Fixation" (ISO 7206-9) .
Final results from these tests demonstrate that the devices meet established acceptance criteria in accordance with the identified industry standards.
Testing to document the required information for the vacuum plasma spray applied surface coating has been previously performed per guidelines established in CDRH Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Cement. This documentation exists in the Bio-Coat Master Device File MAF-1085 of which Arthrosurface has been qiven authorization to reference in support of this 510(k) submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K781870, K864492, K023770, K971047, K911378
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3730 Toe joint phalangeal (hemi-toe) polymer prosthesis.
(a)
Identification. A toe joint phalangeal (hemi-toe) polymer prosthesis is a device made of silicone elastomer intended to be implanted to replace the base of the proximal phalanx of the toe.(b)
Classification. Class II.
0
K031859 pg
510(k) Premarket Notification CAP™ Great Toe Resurfacing Hemi-arthroplasty Implant
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS (21 CFR 807.92) [21 CFR 807.87(H)]
CAP™ GREAT TOE RESURFACING HEMI-ARTHROPLASTY IMPLANT
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807.87(h), this information serves as a Summary of Safety and Effectiveness for the CAP™ Great Toe Resurfacing Hemi-arthroplasty implant.
| Submitted By: | STD Manufacturing, Inc.
1063 Turnpike Street
Stoughton, MA 02072
(781) 828-4400 |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | May 30, 2003 |
| Contact Person: | Steven W. Ek, VP of Development |
| Proprietary Name: | CAP™ Great Toe Resurfacing Hemi-arthroplasty
implant |
| Common Name: | Toe joint, Phalangeal (hemi-toe) prosthesis |
| Classification Name: | Toe joint phalangeal (hemi-toe) prosthesis |
| Device Classification: | Class II |
| Review Panel: | Orthopedic |
| C.F.R. identification
reference: | 21 CFR § 888.3730 (2002) |
| Product Code: | KWD |
| Indications for Use: | Hemi arthroplasty implant for first
metatarsophalangeal joint for use in the treatment
of patients with degenerative and post-traumatic
arthritis in the first metatarsal joint in the presence
of good bone stock along with the following clinical
conditions; hallux valgus or hallux limitus, hallux |
1
rigidus, and an unstable or painful metatarsal/phalangeal (MTP) joint. The device is a single use implant intended to be used with bone cement.
Substantial Equivalence Information:
The intended use, materials, and application of the Proposed device are substantially equivalent to those of the predicate devices. In determining substantial equivalence. STD Manufacturing's device. CAP™ Great Toe Resurfacing Hemi-arthroplasty implant, has been compared with the following legally marketed device to which the submitter claims equivalence.
- Implant, H.P. condylar, Dow Corning Wright (K781870) .
- � Swanson Titanium Great Toe Implant, Dow Corning Wright (K864492)
- . K2 Hemi-Toe Implant System, Kinetikos Medical, Inc. (K023770)
- Futura Biomedical Metal Hemi Toe Implant, Futura Biomedical((K971047) .
- . Townley Great Toe Joint, Biopro, Inc.(K911378)
Device Description and Implantation Summary
The CAP™ Great Toe Resurfacinq Hemi-arthroplasty implant is a cobalt chrome alloy, 2-piece implant to supplement first metatarsal phalangeal joint arthroplasty. The implant is designed to provide a smooth surface for the first metatarsophalangeal joint as a the treatment of patients with degenerative and post-traumatic arthritis in the first metatarsal joint in the presence of good bone stock along with the following clinical conditions; hallux valqus or hallux limitus, hallux rigidus, and an unstable or painful metatarsal/phalangeal (MTP) joint. The device is a single use implant intended to be used with bone cement.
The CAP™ Great Toe Resurfacing Hemi-arthroplasty implant consists of two components, a taper post component and an articular component, that mate together via a taper interlock to provide stable and immobile fixation of the implant and stress bearing contact at the bone/prosthetic interface.
The first implant component is a Taper Post manufactured of a Ti-6AI-4V ELI alloy per ASTM F136. The Taper Post has a tapering distal tip, a full-length cannulation, and a proximal female taper bore.
The second implant is an articular component manufactured of a Cobalt-Chromium-Molybdenum alloy per ASTM F799 and ASTM F1537. The articular component has a bone contact surface that is coated with a CP Titanium coating
2
K031859
page 2 of 6
and a polished articular bearing surface. For greater detail, refer to section 8.2 to view engineering drawings illustrating the various components.
Utilizing the drill guide provided within the CAP™ Great Toe Resurfacing Hemiarthroplasty implant instrumentation set, a surgeon is able to define a working axis that is normal to the articular cartilage surface at the site of the defect. After drilling a pilot hole, theTaper Post is screwed into place using the trial cap to ensure that the surface of the articular component will be tangent and congruent to the existing cartilage surface when seated. Using the contact probe instrument to the explant diameter, offset measurements are taken to define the topography of the patients surrounding articular surface by revolving the probe around a centering shaft coaxial to the working axis of the Taper Post. With these offset measurements, the surgeon is able to select the articular component (sized to match great toe metatarsal head) that will allow it to seat flush to the surrounding articular surface. Offset increments in .5mm sizes will allow for an optimal fit to the existing articular surface.
A reamer, which matches the articular component internal geometry is used to prepare the site for the prosthetic to be implanted. This allows for a precise fit of the implant to the prepared site and minimizes bone resection, so as to provide minimal impact to any future arthroplasty procedure. The articular component is then impacted to seat the taper interlock between the two components.
The prosthetic is intended to provide an effective means for treatment of patients with degenerative and post-traumatic arthritis, hallux valgus, hallux rigidus, hallux limitus, and/or an unstable or painful metatarsal/phalangeal (MTP) joint.
The device has been designed to offer a number of clinical benefits to the user and patient. The device is technically easy to implant, and offers the surgeon a high degree of precision and flexibility in sizing and fitting the articular component to the existing anatomy. A reduction in bone and articular cartilage resection is also offered over the predicate devices, providing a more physiologically normal joint in terms of load and impact distribution.
Non-clinical Testing conducted to determine substantial equivalence with the predicate devices
Mechanical test protocol has been completed using the proposed device including testing of the taper post component and the articular component per the guidelines established in CDRH Guidance Document for Testing Non-Articulating, Mechanically Locked, Modular Implant Components and ASTM F 1814 "Standard Guide for Evaluating Modular Hip and Knee Joint Components".
3
K031859
page 4 of 6
The following non-clinical tests were conducted to assess the device performance:
- Axial Assembly and Disassembly .
- Rigidity Characterization �
- Cyclic Fatigue Failure, Disassembly �
- Fretting, Fretting/ Corrosion (ASTM F897) .
- Resistance to Torque of Head Fixation" (ISO 7206-9) .
Final results from these tests demonstrate that the devices meet established acceptance criteria in accordance with the identified industry standards.
Testing to document the required information for the vacuum plasma spray applied surface coating has been previously performed per guidelines established in CDRH Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Cement. This documentation exists in the Bio-Coat Master Device File MAF-1085 of which Arthrosurface has been qiven authorization to reference in support of this 510(k) submission.
4
t) Premarket Notification
™ Great Toe Resurfacing Hemi-arthroplasty Imp
edicate Devic ownley Great
mplant ticular Surfac o bone ceme lone contacti
urface obalt Chrom obalt Chrom Biopro, In