(108 days)
Not Found
No
The document describes a mechanical shoulder prosthesis and its intended uses. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance studies are mechanical tests, not related to data analysis or image processing.
Yes
This device is a shoulder prosthesis stem, which is used to replace a damaged shoulder joint to alleviate pain and dysfunction. This falls under the definition of a therapeutic device as it treats a medical condition.
No
Explanation: The device is a shoulder prosthesis stem, which is an implant used for joint replacement. Its function is to replace damaged anatomical structures and restore function, not to diagnose a condition.
No
The device description clearly details a physical implant (humeral stem) made of titanium alloy with specific physical features and intended for surgical implantation. This is a hardware medical device, 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 a surgical implant for replacing the shoulder joint in patients with various conditions. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The description details the physical characteristics and materials of a prosthetic implant designed to be surgically placed in the shoulder.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
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
Anatomic Total Shoulder Indications:
The Encore® Shoulder Prosthesis Stem is indicated as an Anatomic shoulder joint replacement for patients suffering from pain and dysfunction due to:
- Noninflammatory degenerative joint disease including osteoarthritis;
- Inflammatory arthritis of the glenohumeral join including rheumatoid arthritis;
- Post-traumatic arthritis of the glenohumeral joint; ●
- Avascular necrosis of the humeral head with and without involvement of the glenoid;
- Correction of functional deformity
The all-poly glenoid is intended for cemented use
Hemi Shoulder Indications:
The Encore® Shoulder Prosthesis Stem is indicated as a hemi shoulder joint replacement for patients suffering from pain and dysfunction due to:
- Noninflammatory degenerative degenerative joint disease including osteoarthritis;
- 0 Inflammatory arthritis of the glenohumeral joint including rheumatoid arthritis;
- 0 Post-traumatic arthritis of the glenohumeral joint;
- Avascular necrosis of the humeral head with and without involvement of the glenoid: ●
- Correction of functional deformity; 0
- Rotator cuff tear arthropathy; ●
- Humeral fracture. ●
- o Failed previous shoulder surgery
Reverse Total Shoulder Indications:
The Encore® Shoulder Prosthesis Stem is as a reverse shoulder replacement for patients with a functional deltoid muscle and a grossly deficient rotator cuff joint suffering from pain and dysfunction due to:
- Severe arthropathy with a grossly deficient rotator cuff; ●
- Previously failed joint replacement with a grossly deficient rotator cuff; ●
- Fracture of glenohumeral joint from trauma or pathologic conditions of the shoulder including humeral ● head fracture, displaced 3- or 4-part fractures of proximal humerus, or reconstruction after turnor resection;
- o Bone defect in proximal humerus:
- Non-inflammatory degenerative disease including osteoarthritis and avascular necrosis of the natural ● humeral head and/or glenoid;
- Inflammatory arthritis including rheumatoid arthritis;
- o Correction of functional deformity.
The glenoid baseplate is intended for cementless application of screws for fixation. This device may also be indicated in the salvage of previously failed surgical attempts for anatomic and hemi procedures
All humeral stems are intended for cemented or cementless use.
Product codes (comma separated list FDA assigned to the subject device)
PHX, KWS, HSD
Device Description
The Encore® Shoulder humeral stem is a single component manufactured from wrought/forged titanium allov. The stem distal body is cylindrical with four flutes. The stem's body flares proximally to a trapezoidal crosssectional midbody, and a hemispherical shell is most superior. The stem has porous coating applied on, and around, the outer spherical diameter of the shell. Porous coating is applied, under the shell, to the stem's medial, anterior, and posterior surfaces. Two fins are located in symmetry on the stem's antero-lateral midbody corners to promote shoulder humeral fracture tuberosity reduction in addition to providing rotational stability. The fins protrude at 45° from the frontal plane. Each fin has two suture holes for reattachment of soft tissue or bone fragments in cases of proximal humeral fracture. A larger hole is located under the steel 's shell which traverses the stem body through the medial-lateral plane to allow through a cerclage wire or suture anchorage point. Four suture holes are located through the stem's shell to aid in soft tissue reattachment and fractured shoulder tuberosity reduction. A larger hole spans the stem's midbody within the medial-lateral plane. The hole is tapered to maintain constant stem wall thickness without compromising fatigue strength. This hole can be used for temporary or long-term bone graft fixation in addition to soft-tissue reattachment. Three slots are located through the stem's shell: anterior, posterior, and medial. These slots allow surgical access by osteotome, or other instruments, for stem removal and separation from bone during revision surgery. A central screw thread within the stem's shell allows mating interface with other surgical instruments or implants.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, glenohumeral joint, humeral head, proximal humerus
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)
Non-Clinical Testing: Mechanical testing has demonstrated the device's ability to perform under expected conditions. Testing included snap mechanism verification tolerance analysis, statistical modal analysis and fatigue testing. All testing has determined that the device is substantially equivalent to the predicate devices.
Clinical Testing: None provided.
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.
K100741, K111735, K130048, K103208, K140904, K080402, K950651, K950594, K082120, K122698
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
§ 888.3660 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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 7, 2014
Encore Medical, L.P. Ms. Teffany Hutto Manager, Regulatory Affairs 9800 Metric Boulevard Austin, Texas 78758
Re: K141990
Trade/Device Name: Encore Humeral Shoulder Stem Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX, KWS, HSD Dated: October 16, 2014 Received: October 17, 2014
Dear Ms. Hutto:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
Page 2 - Ms. Teffany Hutto
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Lori A. Wiggins -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known):
Device Name: Encore Humeral Shoulder Stem
Indications for Use:
Encore Humeral Shoulder Stem Indications for Use
Anatomic Total Shoulder Indications:
The Encore® Shoulder Prosthesis Stem is indicated as an Anatomic shoulder joint replacement for patients suffering from pain and dysfunction due to:
- 0 Noninflammatory degenerative joint disease including osteoarthritis;
- Inflammatory arthritis of the glenohumeral join including rheumatoid arthritis;
- Post-traumatic arthritis of the glenohumeral joint; ●
- Avascular necrosis of the humeral head with and without involvement of the glenoid;
- Correction of functional deformity
The all-poly glenoid is intended for cemented use
Hemi Shoulder Indications:
The Encore® Shoulder Prosthesis Stem is indicated as a hemi shoulder joint replacement for patients suffering from pain and dysfunction due to:
- 0 Noninflammatory degenerative joint disease including osteoarthritis;
- 0 Inflammatory arthritis of the glenohumeral joint including rheumatoid arthritis;
- 0 Post-traumatic arthritis of the glenohumeral joint;
- Avascular necrosis of the humeral head with and without involvement of the glenoid: ●
- Correction of functional deformity; 0
- Rotator cuff tear arthropathy; ●
- Humeral fracture. ●
- o Failed previous shoulder surgery
Reverse Total Shoulder Indications:
The Encore® Shoulder Prosthesis Stem is as a reverse shoulder replacement for patients with a functional deltoid muscle and a grossly deficient rotator cuff joint suffering from pain and dysfunction due to:
- Severe arthropathy with a grossly deficient rotator cuff; ●
- Previously failed joint replacement with a grossly deficient rotator cuff; ●
- Fracture of glenohumeral joint from trauma or pathologic conditions of the shoulder including humeral ● head fracture, displaced 3- or 4-part fractures of proximal humerus, or reconstruction after turnor resection;
- o Bone defect in proximal humerus:
- Non-inflammatory degenerative disease including osteoarthritis and avascular necrosis of the natural ● humeral head and/or glenoid;
- Inflammatory arthritis including rheumatoid arthritis;
- o Correction of functional deformity.
The glenoid baseplate is intended for cementless application of screws for fixation. This device may also be indicated in the salvage of previously failed surgical attempts for anatomic and hemi procedures
All humeral stems are intended for cemented or cementless use.
3
510(k) Number (if known): _K141990 Device Name: Encore Humeral Shoulder Stem
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
4
510(k) Summary
Date: November 6, 2014
Manufacturer: DJO Surgical (Legal Name: Encore Medical, L.P.) 9800 Metric Blvd Austin, TX 78758
Contact Person: Teffany Hutto Manager, Regulatory Affairs Phone: (512) 834-6255 Fax: (512) 834-6313 Email: teffany.hutto@djoglobal.com
| Product | Classification | Product Code | Product Code | Regulation and Classification Name |
|---|---|---|---|---|
| Encore Humeral Shoulder Stem | Class II | KWS, HSD, PHX | KWS | Shoulder joint metal/polymer semi-constrained prosthesis per 21 CFR 888.3660 |
| HSD | Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis per 21 CFR 888.3690 | |||
| PHX | Shoulder joint metal/polymer semi-constrained cemented prosthesis per 21 CFR 888.3660 |
Description:
The Encore® Shoulder humeral stem is a single component manufactured from wrought/forged titanium allov. The stem distal body is cylindrical with four flutes. The stem's body flares proximally to a trapezoidal crosssectional midbody, and a hemispherical shell is most superior. The stem has porous coating applied on, and around, the outer spherical diameter of the shell. Porous coating is applied, under the shell, to the stem's medial, anterior, and posterior surfaces. Two fins are located in symmetry on the stem's antero-lateral midbody corners to promote shoulder humeral fracture tuberosity reduction in addition to providing rotational stability. The fins protrude at 45° from the frontal plane. Each fin has two suture holes for reattachment of soft tissue or bone fragments in cases of proximal humeral fracture. A larger hole is located under the steel 's shell which traverses the stem body through the medial-lateral plane to allow through a cerclage wire or suture anchorage point. Four suture holes are located through the stem's shell to aid in soft tissue reattachment and fractured shoulder tuberosity reduction. A larger hole spans the stem's midbody within the medial-lateral plane. The hole is tapered to maintain constant stem wall thickness without compromising fatigue strength. This hole can be used for temporary or long-term bone graft fixation in addition to soft-tissue reattachment. Three slots are located through the stem's shell: anterior, posterior, and medial. These slots allow surgical access by osteotome, or other instruments, for stem removal and separation from bone during revision surgery. A central screw thread within the stem's shell allows mating interface with other surgical instruments or implants.
Indications for Use:
Anatomic Total Shoulder Indications:
The Encore® Shoulder Prosthesis Stem is indicated as an Anatomic shoulder joint replacement for patients suffering from pain and dysfunction due to:
- Noninflammatory degenerative joint disease including osteoarthritis;
- Inflammatory arthritis of the glenohumeral join including rheumatoid arthritis;
- . Post-traumatic arthritis of the glenohumeral joint;
- Avascular necrosis of the humeral head with and without involvement of the glenoid; ●
- Correction of functional deformity ●
The all-poly glenoid is intended for cemented use
Hemi Shoulder Indications:
The Encore@Shoulder Prosthesis Stem is indicated as a hemi shoulder joint replacement for patients suffering from pain and dysfunction due to:
- Noninflammatory degenerative joint disease including osteoarthritis;
- Inflammatory arthritis of the glenohumeral joint including rheumatoid arthritis; ●
- Post-traumatic arthritis of the glenohumeral joint; .
5
- Avascular necrosis of the humeral head with and without involvement of the glenoid; ●
- . Correction of functional deformity;
- . Rotator cuff tear arthropathy;
- Humeral fracture.
- . Failed previous shoulder surgery
Reverse Total Shoulder Indications:
The Encore® Shoulder Prosthesis Stem is as a reverse shoulder replacement with a functional deltoid muscle and a grossly deficient rotator cuff joint suffering from pain and dysfunction due to:
- . Severe arthropathy with a grossly deficient rotator cuff;
- . Previously failed joint replacement with a grossly deficient rotator cuff;
- Fracture of glenohumeral joint from trauma or pathologic conditions of the shoulder including humeral ● head fracture, displaced 3- or 4-part fractures of proximal humerus, or reconstruction after tumor resection;
- Bone defect in proximal humerus;
- Non-inflammatory degenerative disease including osteoarthritis and avascular necrosis of the natural humeral head and/or glenoid;
- Inflammatory arthritis including rheumatoid arthritis;
- Correction of functional deformity.
The glenoid baseplate is intended for cementless application with addition of screws for fixation. This device may also be indicated in the salvage of previously failed surgical attempts for anatomic and hemi procedures
All humeral stems are intended for cemented or cementless use.
Predicate Devices:
- Reverse® Shoulder Prosthesis Monoblock K100741, K111735, K130048, K103208, K140904 ●
- Encore® Shoulder System - K080402
- Foundation Shoulder System - K950651
- Encore® Hemi Shoulder - K950594
- Torneir Aequalis® Reversed Fracture Shoulder Prosthesis - K082120
- Tornier Aequalis® Flex Shoulder System - K122698
Comparable Features to Predicate Device(s): Features comparable to predicate devices include the same material substrate, same porous coating material, surface finishes, size offering, mating interface snap mechanism, sterilization and packaging, and surgical implantation technique. Differences to the predicates include additional size offerings, location of fins, location and quantity of suture holes, P2 porous coating surface area, and midbody cross-sectional shape, and metaphysis window shape and orientation.
Non-Clinical Testing: Mechanical testing has demonstrated the device's ability to perform under expected conditions. Testing included snap mechanism verification tolerance analysis, statistical modal analysis and fatigue testing. All testing has determined that the device is substantially equivalent to the predicate devices.
Clinical Testing: None provided.