(57 days)
No
The summary describes a physical implant made of standard medical-grade materials and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI/ML.
Yes
The device is intended to be used in arthroplasty for patients with osteoarthritis, patellar dislocation, or patellar fracture, all of which are medical conditions that the device aims to treat or correct.
No
The device is a prosthesis intended for surgical arthroplasty, replacing parts of a joint. It is not designed to identify existing medical conditions or diseases.
No
The device description clearly details physical components made of metal alloys and polyethylene, indicating it is a hardware medical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a surgical implant for treating osteoarthritis and other conditions in the patello-femoral joint. This is a therapeutic intervention, not a diagnostic test performed on samples from the body.
- Device Description: The device is a physical prosthesis made of metal and polyethylene, designed to be implanted into the body. IVD devices are typically reagents, instruments, or systems used to examine specimens like blood, urine, or tissue.
- No mention of in vitro testing: The description focuses on the materials and design of the implant, not on any tests performed outside of the body.
Therefore, the HemiCAP™ Patello-femoral Resurfacing Prosthesis is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The HemiCAP™ Patello-femoral Resurfacing Prosthesis is intended to be used in cemented arthroplasty in patients with osteoarthritis limited to the distal patello-femoral joint, patients with a history of patellar dislocation or patellar fracture, and those patients with failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release, etc.) where pain, deformity or dysfunction persists.
Product codes
KRR
Device Description
The HemiCAP™ Patello-Femoral Resurfacing Prosthesis incorporates a distal femoral trochlear surface articular component that mates to a fixation stud via a taper interlock, and an allpolyethylene patella component. The prosthesis is intended to be used in cemented arthroplasty.
The femoral articular component is manufactured of a Cobalt-Chromium-Molybdenum alloy per ASTM F799 and ASTM F1537. The component has a bone contact surface that is coated with a spray-applied CP Titanium coating and a polished articular bearing surface. The fixation stud component is a short tapered cylinder, 13mm in length, manufactured of a Ti-6Al-4V ELI alloy per ASTM F136. The stud has a tapering helix, a full-length cannulation, and a proximal female taper bore. The patella prosthesis component is comprised of ultra-high-molecular weight polyethylene (UHMWPE) manufactured and tested to meet standards specified in ASTM F 648-04, Type I. The materials, manufacturing methods, and surface finish requirements for these components are identical to those used for the Sponsor's previously cleared devices (K021549, K023096, K031859, K050373).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal patello-femoral joint
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
Non-Clinical Performance Testing completed as part of the Arthrosurface Design Control Procedure has demonstrated that the device is safe and substantially equivalent to the predicate devices. Clinical data was not needed for this device.
Key Metrics
Not Found
Predicate Device(s)
K021549, K023096, K031859, K050373
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3540 Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis is a two-part device intended to be implanted to replace part of a knee joint in the treatment of primary patellofemoral arthritis or chondromalacia. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes a component made of alloys, such as cobalt-chromium-molybdenum or austenitic steel, for resurfacing the intercondylar groove (femoral sulcus) on the anterior aspect of the distal femur, and a patellar component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those devices intended for use with bone cement (§ 888.3027). The patellar component is designed to be implanted only with its femoral component.(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Applications for Orthopedic Devices,” and
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,” and
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-Aluminum 4-Vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-Chromium-Molybdenum Casting Alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-Chromium-Molybdenum Alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,”
(vii) ISO 7207-2:1998 “Implants for Surgery—Components for Partial and Total Knee Joint Prostheses—Part 2: Articulating Surfaces Made of Metal, Ceramic and Plastic Materials,” and
(viii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(v) F 1108-97 “Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings,”
(vii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants,” and
(viii) F 1672-95 “Specification for Resurfacing Patellar Prosthesis.”
0
MAR 1 5 2006
Kobo127 page 1 of 2
HemiCAP™ Patello-Femoral Resurfacing Prosthesis
510(K) Summary
Of Safety and Effectiveness
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe In accordance with the Food and Drug Administration of this information serves as a Medical Devices Act of 1990 and in Conformance with 21 Of Poor, Che Michilder Status Prosthesis.
| Submitted By: | Arthrosurface, Inc.
28 Forge Parkway
Franklin, MA 02038
(508) 520-3003 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | 16 January 2006 |
| Contact Person: | Steven W. Ek
Chief Operations Officer |
| Proprietary Name: | HemiCAP™ Patello-Femoral Resurfacing Prosthesis |
| Common Name: | Knee Joint Patellofemoral polymer/metal semi-constrained
cemented prosthesis |
| Classification Name: | Knee Joint Patello-femoral Resurfacing Prosthesis
Orthopedic
21 CFR § 888.3540 (2003)
Class II |
| Product Code: | KRR |
| Indications for Use: | The HemiCAP™ Patello-femoral Resurfacing Prosthesis is intended to be used in cemented arthroplasty in patients with osteoarthritis limited to the distal patello-femoral joint, patients with a history of patellar dislocation or patellar fracture, and those patients with failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release, etc.) where pain, deformity or dysfunction persists. |
K060127; HemiCAP® Patello-Femoral Resurfacing Prosthesis
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