(29 days)
Not Found
No
The document describes a mechanical orthopedic implant (humeral stems and heads) and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is used for the partial or total replacement of the human shoulder joint to treat various conditions like fractures, avascular necrosis, and arthritis, which are therapeutic interventions.
No
Explanation: The device is described as an orthopedic implant for shoulder joint replacement, not for diagnostic purposes.
No
The device description clearly states the devices are "modular humeral stems and humeral heads," which are physical orthopedic implants, 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 states that the device is an orthopedic implant for the partial or total replacement of the human shoulder joint. This is a surgical procedure performed in vivo (within the body).
- Device Description: The device is described as modular humeral stems and humeral heads, which are physical 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 in vitro (outside the body) to analyze biological samples. This device is a surgical implant used in vivo.
N/A
Intended Use / Indications for Use
Modular Neer 3 Humeral Stems and 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. Modular Neer 3 Humeral Stems and Humeral Heads are intended for use with bone cement (cemented fixation) and for single use only. Modular Neer 3 Humeral Stems and 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 impression fractures); (2) complex, chronic fracture-dislocations of the humeral head with malunion, nonunion 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, osteourthritis, traumatic arthritis, cuff tear arthroplasty, ancient septic arthritis, avascular necrosis with secondary glenoid changes, radiation necrosis, and other failed reconstructive procedures.
Product codes
KWS
Device Description
The subject devices are modular humeral stems and humeral heads. They are designed for use with existing Neer II, Neer III, and Cofield2 Total Shoulder System glenoid components.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Design Verification Test results indicate that the subject devices meet the requirements of the applicable FDA guidance documents.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K955767, K003566, K952928, K982981
Reference Device(s)
Not Found
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
MAR 04 2003
03 44
page 1 of 1
510(k) Summary Modular Neer 3 Humeral Stems and Humeral Heads
| 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: | January 30, 2003 |
| Trade or proprietary device name: | Modular Neer 3 Humeral Stems and 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
Modular Neer 3 Humeral Stems and Humeral Heads are substantially equivalent to Smith & Nephew Cofield2 Total Shoulder System humeral stems and humeral heads (K955767 and K003566), Tornier, S.A. Aequalis™ Shoulder System (K952928), and the New Zimmer Shoulder System (K982981),
Device Description
The subject devices are modular humeral stems and humeral heads. They are designed for use with existing Neer II, Neer III, and Cofield2 Total Shoulder System glenoid components.
Device Intended Use
Modular Neer 3 Humeral Stems and 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. Modular Neer 3 Humeral Stems and Humeral Heads are intenced for use with bone cement (cemented fixation) and for single use only. Modular Neer 3 Humeral Stems and 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 impression fractures); (2) complex, chronic fracture-dislocations of the humeral head with malunion, nonunion 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, osteourthritis, traumatic arthritis, cuff tear arthroplasty, ancient septic arthritis, avascular necrosis with secondary glenoid changes, radiation necrosis, and other failed reconstructive procedures.
Technological and Performance Characteristics:
Modular Neer 3 Humeral Stems and Humeral Heads are similar to the legally marketed predicate devices listed above. All of these devices are indicated for total shoulder arthroplasty or hemiarthroplasty. They are similar in design to the subject devices and have the same technological characteristics. The safety and effectiveness for the subject devices is adequately supported by test data, material information, and substantial equivalence information provided in this Special 510(k) Premarket Notification. Design Verification Test results indicate that the subject devices meet the requirements of the applicable FDA guidance documents.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 0 4 2003
Mr. David Henley Senior Clinical/Regulatory Affairs Specialist Smith & Nephew, Inc. Orthonedic Division 1450 Brooks Road Memphis. TN 38116
Re: K030344
Trade/Device Name: Modular Neer 3 Humeral Stems and Heads Regulation Number: 7821 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: KWS Dated: January 30, 2003 Received: February 3, 2003
Dear Mr. Henley:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
2
Page 2 - Mr. David Henley
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
lo Mark N Millan
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Premarket Notification Indications Enclosure
510(k) Number (if known): K030344
Device Name: Modular Neer 3 Humeral Stems and Humeral Heads
Indications for Use:
Modular Neer 3 Humeral Stems and 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 gleno d face or a compatible glenoid component, respectively. Modular Neer 3 Humeral Stems and Humeral Heads are intended for use with bone cement (cemented fixation) and for single use only. Modular Neer 3 Humeral Stems and 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 cartillige; and (4) selected patients with arthritis who do not have adequate scapular bone to support a glerioid 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, osteoarthritis, traumatic arthroplasty, ancient septic arthritis, avascular necrosis with secondary glenoid changes, radiation necrosis, and other failed reconstructive procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
for Mark N. Milkenos
Lestorative and Neurological D. ces
2(k) Number_
Prescription Use
(Per 21 CFR 801.109)
OR
Over-the-Counter Use No (Optional Format 1-2-96)