(140 days)
No
The document describes a mechanical orthopedic implant (humeral head) made of metal. There is no mention of software, algorithms, data processing, or any terms related to AI/ML. The performance studies are mechanical tests, not algorithmic evaluations.
No.
The device is an orthopedic implant for partial or total replacement of the shoulder joint, which is a restorative rather than therapeutic function.
No
This device is a prosthetic implant for shoulder replacement, intended for therapeutic use to replace damaged or diseased portions of the shoulder joint, rather than to diagnose conditions.
No
The device description explicitly states that the device is manufactured from forged cobalt chrome and titanium, indicating it is a physical implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as an orthopedic implant for the partial or total replacement of the human shoulder joint. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as being manufactured from forged cobalt chrome and titanium, materials used for surgical implants.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used outside the body to analyze biological samples. This device is a surgical implant used inside the body.
N/A
Intended Use / Indications for Use
The subject humeral head devices can be mated with approved humeral stem components from the Cofield Total Shoulder System previously cleared for market under K955767. 3D Humeral Heads are indicated for use as orthopedic implants for the partial or total replacement of the human shoulder joint articulating either directly against the glenoid face or a compatible glenoid component, respectively. 3D Humeral Heads are intended for use with bone cement only (cemented fixation) and for single use only. 3D Humeral Heads are intended for the following indications:
Proximal Humeral Prosthesis – (1) complex, acute fractures or fracture-dislocations of the humeral head (e.g. trauma - three and four-part injuries in the Neer classification, or head splitting, or head impression fractures); (2) complex, chronic fractures or fracture-dislocations of the humeral head with malunion, non-union of a small osteoporotic head fragment, or chronic dislocation with loss of humeral head cartilage, or large impression fractures; (3) avascular necrosis with intact glenoid cartilage; and (4) selected patients with arthritis who do not have adequate scapular bone to support a glenoid component or must engage in moderately heavy activities.
Total Shoulder Arthroplasty (when used in conjunction with a compatible glenoid component) severe destruction of the glenohumeral articular surfaces with intractable chronic pain in rheumatoid arthritis, osteoarthriis, traumatic arthritis, cuff tear arthroplasty, ancient septic arthritis, avascular necrosis with secondary glenoid changes, radiation necrosis, and other failed reconstructive procedures.
Product codes
KWS, HSD
Device Description
3D humeral heads are manufactured from forged cobalt chrome (CoCr) material (ASTM F799) and can be used with existing cobalt chrome humeral stem components from the Cofield Total Shoulder System previously cleared from market. 3D taper sleeves are manufactured from titanium (Ti-6Al-4V) material conforming to the requirements of ASTM F1472.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder Joint, Proximal Humeral
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)
Mechanical humeral head distraction testing and ion release analysis was performed on these devices. Results indicate that the subject devices meet or exceed acceptable performance. Data indicate that 3D Humeral Heads are substantially equivalent to legally marketed devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. 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 prostheses that have a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (§ 888.3027).(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)) Application for Orthopedic Devices,” and
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,”
(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,” and
(vii) 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 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal,”
(vii) F 1378-97 “Standard Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”
0
A 510(k) Summary of Safety and Effectiveness
DEC 1 3 2001
| Submitter's name: | Smith & Nephew, Inc., Orthopaedic Division |
|---|---|
| Submitter's address: | 1450 Brooks Road, Memphis, TN 38116 |
| Submitter's telephone number: | 901-399-6487 |
| Contact person: | David Henley, Senior Clinical/Regulatory Affairs Specialist |
| Date summary prepared: | July 25, 2001 |
| Trade or proprietary device name: | 3D Humeral Heads |
| Common or usual name: | Shoulder Joint Prosthesis |
| Classification name: | 21 CFR 888.3660, shoulder joint metal/polymer, semi- |
| constrained cemented prosthesis - Class II |
Substantially Equivalent Legally Marketed Devices
- AequalisTM Shoulder System Tornier, S.A. .
- Anatomica Humeral Stems/Heads Sulzer Orthopedics .
Device Description
3D humeral heads are manufactured from forged cobalt chrome (CoCr) material (ASTM F799) and can be used with existing cobalt chrome humeral stem components from the Cofield' Total Shoulder System previously cleared from market. 3D taper sleeves are manufactured from titanium (Ti-6Al-4V) material conforming to the requirements of ASTM F1472.
Device Intended Use
The subject humeral head devices can be mated with approved humeral stem components from the Cofield Total Shoulder System previously cleared for market under K955767. 3D Humeral Heads are indicated for use as orthopedic implants for the partial or total replacement of the human shoulder joint articulating either directly against the glenoid face or a compatible glenoid component, respectively. 3D Humeral Heads are intended for use with bone cement only (cemented fixation) and for single use only. 3D Humeral Heads are intended for the following indications:
Proximal Humeral Prosthesis – (1) complex, acute fractures or fracture-dislocations of the humeral head (e.g. trauma - three and four-part injuries in the Neer classification, or head splitting, or head impression fractures); (2) complex, chronic fractures or fracture-dislocations of the humeral head with malunion, non-union of a small osteoporotic head fragment, or chronic dislocation with loss of humeral head cartilage, or large impression fractures; (3) avascular necrosis with intact glenoid cartilage; and (4) selected patients with arthritis who do not have adequate scapular bone to support a glenoid component or must engage in moderately heavy activities.
1