(67 days)
No
The description focuses on the mechanical design, materials, and surgical application of a humeral head resurfacing system. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended for resurfacing the humeral head in patients with arthritis or post-traumatic arthritis, which are conditions that impair function and cause pain, and the device aims to restore normal anatomy and improve patient well-being, thus providing therapeutic benefit.
No
The device is an implant for resurfacing the humeral head, not a tool for diagnosing medical conditions.
No
The device description clearly states it is a monolithic device designed for resurfacing the humeral head, made from Cobalt Chrome, and includes a stem. This describes 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 a surgical implant for replacing a damaged part of the humeral head due to various arthritic conditions. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a physical implant made of metal alloys designed for surgical implantation and bone integration. This is consistent with a medical device used for treatment, not for analyzing samples from the body to diagnose a condition.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
Therefore, the Ascension® HRA® System TPS/HA is a medical device intended for surgical treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Ascension® HRA® System TPS/HA is intended for resurfacing of the humeral head due to:
- Patients disabled by either non-inflammatory or inflammatory arthritis (i.e. rheumatoid arthritis, . osteoarthritis and avascular necrosis)
- Mild or moderate humeral head deformity and / or limited motion .
- . Post-traumatic arthritis
- . Patients with an intact or reparable rotator cuff
Product codes
HSD
Device Description
The Ascension® HRA® System TPS/HA includes an anatomically designed, semi-constrained, monolithic device designed for resurfacing of the humeral head (hemi-shoulder). The system is designed for non-cemented (i.e. press-fit) fixation. Each device is boxed individually and delivered sterile for single use. The system incorporates eight anatomically designed head geometries with appropriately sized stems. Head sizes are identified using width and height (in millimeters). The Ascension® HRA® device incorporates design features for replacing the damaged humeral head bearing surface and restoring normal anatomy with minimal bone resection. The stem is tapered and fluted to provide rotational as well as axial stability of the seated implant. System instrumentation, including a range of implant trials, is designed to offer precise implant preparation. The HRA device is made from Cobalt Chrome (ASTM F-1537 wrought or ASTM F-75 cast) and features a highly polished bearing surface with a CP Titanium or HA plasma spray undersurface and stem coating for osseointegration. No new materials are introduced with this device. Ascension® HRA® System components will be manufactured by contract manufacturers per Ascension Orthopedics, Inc., specifications.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
humeral head
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K062861, K010664, K010827, K051843, K031971, K033516
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3690 Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.
(a)
Identification. A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium-molybdenum. It has an intramedullary stem and is intended to be implanted to replace the articular surface of the proximal end of the humerus and to be fixed without bone cement (§ 888.3027). This device is not intended for biological fixation.(b)
Classification. Class II.
0
510(k) SUMMARY
| K071064 | (pg 1/3) |
|---|---|
| --------- | ---------- |
| SUBMITTER NAME: | Ascension Orthopedics, Inc.
8700 Cameron Road, C-100
Austin, TX 78754-3832 | |
|-----------------|----------------------------------------------------------------------------------|--------------|
| 510(k) CONTACT: | Glen Neally
Phone: (512) 836-5001 | JUN 2 2 2007 |
| TRADE NAME: | Ascension® HRA® System TPS/HA | |
| COMMON NAME: | Sterile Resurfacing Shoulder Joint Replacement Prosthesis | |
| CLASSIFICATION: | 21 CFR 888.3690 | |
| PRODUCT CODE: | HSD | |
| PANEL: | Orthopedic | |
PREDICATE DEVICES:
Biomet Coneland Humeral Resurfacing Head (K010664, K010827 and K051843) DePuy Global C.A.P. (K031971 and K033516) Ascension® Humeral Resurfacing Arthroplasty (HRA) System (K062861)
DEVICE DESCRIPTION:
The Ascension® HRA® System TPS/HA includes an anatomically designed, semi-constrained, monolithic device designed for resurfacing of the humeral head (hemi-shoulder). The system is designed for noncemented (i.e. press-fit) fixation. Each device is boxed individually and delivered sterile for single use. The system incorporates eight anatomically designed head geometries with appropriately sized stems. Head sizes are identified using width and height (in millimeters). The Ascension® HRA® device incorporates design features for replacing the damaged humeral head bearing surface and restoring normal anatomy with minimal bone resection. The stem is tapered and fluted to provide rotational as well as axial stability of the seated implant. System instrumentation, including a range of implant trials, is designed to offer precise implant preparation. The HRA device is made from Cobalt Chrome (ASTM F-1537 wrought or ASTM F-75 cast) and features a highly polished bearing surface with a CP Titanium or HA plasma spray undersurface and stem coating for osseointegration. No new materials are introduced with this device. Ascension® HRA® System components will be manufactured by contract manufacturers per Ascension Orthopedics, Inc., specifications.
INTENDED USE:
The Ascension® HRA® System TPS/HA is intended for resurfacing of the humeral head due to:
- Patients disabled by either non-inflammatory or inflammatory arthritis (i.e. rheumatoid arthritis, . osteoarthritis and avascular necrosis)
- Mild or moderate humeral head deformity and / or limited motion .
1
510(k) Premarket Notification Device: Ascension® Humeral Resurfacing Arthroplasty (HRA) System TPS/HA
-
. Post-traumatic arthritis
K071064 (pg 2/3) -
. Patients with an intact or reparable rotator cuff
BASIS OF SUBSTANTIAL EQUIVALENCE:
A comparison of identical materials and nearly identical design features, demonstrates that the Ascension® HRA® device is substantially equivalent to the predicate device as indicated in the chart below:
| Specification /
Characteristic | Ascension
Orthopedics Inc
(ΑΟΙ)
Humeral Resurfacing
Arthroplasty (HRA)
Device (& TPS/HA) | Biomet / Copeland
Humeral
Resurfacing Head | DePuy / Global
C.A.P. |
|-----------------------------------|---------------------------------------------------------------------------------------------------------|--------------------------------------------------|----------------------------------|
| FDA 510(k) clearance | K062861
(this submission) | K010664, K010827,
and K051843 | K031971 and
K033516 |
| Use | Single use | Single use | Single use |
| Implantation duration | Longer than 30 days | Longer than 30 days | Longer than 30 days |
| Constraint | Semi-constrained | Semi-constrained | Semi-constrained |
| Articulating Surface | ASTM F-75 Co-Cr
Casting Alloy
or ASTM F1537
wrought Co-Cr | ASTM F-75 Co-Cr
Casting Alloy | ASTM F-75 Co-Cr
Casting Alloy |
| Under-Coating | CP Ti (ASTM F1580)
HA (ASTM F 1185-03)
Plasma Spray Coating | CP Ti (ASTM F1580)
Plasma Spray Coating | Porocoat® Porous
Coating |
| Sizes | 8 | 8 | 10 |
| Width Range | 40mm - 56mm | 42.7mm - 54.0mm | 40mm - 56mm |
| Height Range | 15mm - 21mm | 12.0mm - 27.0mm | 15mm - 21mm |
| Radius Range | 20.5mm - 29.2mm | 25mm - 27.5mm | 20.1mm - 30.8mm |
| Shell Thickness (head) | Same | Same | Same |
| Under-surface Flat | No | No | Yes |
| Primary Fixation | Press Fit Stem | Press Fit Stem | Press Fit Stem |
| Tapered Stem | Yes | Yes | Yes |
| Stem Cross-Section | Four-Fluted | Four-Fluted | Four-Fluted |
| Variable Stem Lengths | Yes | Yes | Yes |
| Cannulated
Instrumentation | Yes | Yes | Yes |
| Minimal Bone | Yes | Yes | Yes |
REG-04-901-001 Rev. A
2
510(k) Premarket Notification Device: Ascension® Humeral Resurfacing Arthroplasty (HRA) System TPS/HA
| Removal | |||
|---|---|---|---|
| Penetration of | |||
| Intramedullary Canal | No | No | No |
| Easy Conversion to | |||
| Stemmed Component | Yes | Yes | Yes |
Similarities of the Ascension® HRA® device and the Biomet Copeland and the DePuy Global C.A.P. devices include: All devices have the same indications for use; All devices are made of the same industry standard materials; No new materials are introduced; Minimal bone removal surgical procedure for all device; Anatomic head sizes; All devices incorporate a press-fit stem as the primary fixation method; All devices are intended for surgical implantation longer than 30 days: All devices are intended for single use only.
Summary:
The Ascension® HRA® System TPS/HA is identical functionally, and had the same indications for use when compared to the predicate devices, and is fabricated from the same materials as the predicate devices. Dimensionally, the Ascension® HRA® device is nearly identical to the predicate devices. Devices for the subject and predicate systems are provided sterile in individual packages. Therefore, the Ascension HRA device is substantially equivalent to the predicate devices.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three overlapping wing-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 2 2007
Ascension Orthopedics, Inc. % Mr. Glen Neally Vice President of QA/RA/CA 8700 Cameron Road, Suite 100 Austin, Texas 78754-3832
Re: K071064
Trade/Device Name: Ascension® Humeral Resurfacing Arthroplasty (HRA) System TPS/HA Regulation Number: 21 CFR 888.3690 Regulation Name: Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis Regulatory Class: II Product Code: HSD Dated: April 12, 2007 Received: April 16, 2007
Dear Mr. Neally:
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
4
Page 2 - Mr. Glen Neally
systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 (240) 276-0120. 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 from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Barbara Briem
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications For Use
510(K) Number: K071064 (pg 1/1)
Ascension® Humeral Resurfacing Arthroplasty (HRA) System TPS/HA Device Name:
Indications for Use:
Prescription Use
X
The Ascension® HRA® device is intended for resurfacing of the humeral head due to:
- Patients disabled by either non-inflammatory or inflammatory arthritis (i.e. rheumatoid arthritis, . osteoarthritis and avascular necrosis).
- Mild or moderate humeral head deformity and / or limited motion. �
ાર
- Post-traumatic arthritis. �
- Patients with an intact or reparable rotator cuff. .
(Part 21 CFR 801Subpart C) (Part 21 CFR 801 Subpart B) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY) Concurrence of CDRET Stuges 96 for Stelle Off ODE Division of General, Restorative, and Neurological Devices REG-04-901-001 Rev. A 510(k) I
Over-The-Counter Use