Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the mechanical design, materials, and surgical application of a humeral head resurfacing device. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.

Therapeutic

Yes
The device is described as an implantable system designed for resurfacing the humeral head in patients with various forms of arthritis and head deformities. Its purpose is to replace damaged bearing surfaces and restore normal anatomy, directly treating a medical condition.

Diagnostic

No

The device is described as a surgical implant for resurfacing the humeral head, intended for treatment of various conditions, not for diagnosis.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical implant made of Cobalt Chrome and Titanium, intended for surgical implantation. It also mentions system instrumentation. This is a hardware medical device, not software-only.

IVD (In Vitro Diagnostic)

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 resurfacing the humeral head due to various conditions like arthritis, fractures, and deformities. This is a therapeutic device, not a diagnostic one.
Device Description: The description details a physical implant made of Cobalt Chrome, designed for surgical implantation and bone integration. This is consistent with a surgical device, not a diagnostic test.
Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, tissue, etc.), detecting biomarkers, or providing information for diagnosis.

IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The Ascension® HRA® device is a medical device used in the body for treatment.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Ascension® HRA® System 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
Malunions of the humeral head .
. Acute fractures of the humeral head
. Patients with an intact or reparable rotator cuff

Contraindications:

Infection, sepsis, and osteomyelitis .
. Osteoporosis
Metabolic disorders which may impair bone formation .
. Osteomalacia
. Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
. Revision procedures where other devices or treatments have failed

Product codes (comma separated list FDA assigned to the subject device)

HSD

Device Description

The Ascension® HRA® System 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 plasma spray under-surface and stem coating to enhance 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): 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.

Biomet Copeland Humeral Resurfacing Head (K010664, and K051843), DePuy Global C.A.P. (K031971)

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

Regulation Number and Section

§ 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.

Summary

0

Page 38 of 95

510(k) SUMMARY

| SUBMITTER NAME: | Ascension Orthopedics, Inc.
8700 Cameron Road, C-100
Austin, TX 78754-3832 |
|-----------------|----------------------------------------------------------------------------------|
| | OCT 31 2000 |
| 510(k) CONTACT: | Glen Neally |
| | Phone: (512) 836-5001 |
| TRADE NAME: | Ascension® HRA® |
| COMMON NAME: | Sterile Resurfacing Shoulder Joint Replacement Prosthesis |
| CLASSIFICATION: | 21 CFR 888.3690 |
| PRODUCT CODE: | HSD |
| PANEL: | Orthopedic |

PREDICATE DEVICES:

Biomet Copeland Humeral Resurfacing Head (K010664, and K051843) DePuy Global C.A.P. (K031971)

DEVICE DESCRIPTION:

The Ascension® HRA® System 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 plasma spray under-surface and stem coating to enhance 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 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

61 Page 1/3

1

Malunions of the humeral head .
. Acute fractures of the humeral head
. Patients with an intact or reparable rotator cuff

Contraindications:

Infection, sepsis, and osteomyelitis .
. Osteoporosis
Metabolic disorders which may impair bone formation .
. Osteomalacia
. Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
. Revision procedures where other devices or treatments have failed

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
(AOI)
Humeral Resurfacing
Arthroplasty (HRA)
Device | Biomet / Copeland
Humeral
Resurfacing Head | DePuy / Global
C.A.P. |
|-----------------------------------|----------------------------------------------------------------------------------------------|--------------------------------------------------|----------------------------------|
| FDA 510(k) clearance | K010664, and
K051843 | K010664, and
K051843 | K031971 |
| 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)
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 |

2

Page 40 of 99

Height Range	15mm – 21mm	12.0mm – 27.0mm	15mm – 21mm
Radius Range	20.2mm – 28.7mm	25mm – 27.5mm	20.1mm – 30.8mm
Shell Thickness (head)	Same	Same	Same
Under-surface Flat	Yes	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	Yes	Yes	Yes
Instrumentation
Minimal Bone Removal	Yes	Yes	Yes
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 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 features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The logo is black and white and appears to be a scanned image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 3 1 2006

Ascension Orthopedics, Inc. % Mr. Glen Neally Vice President of RA/QA/CA 8700 Cameron Road, C-100 Austin, Texas 78754-3832

Re: K062861

Trade/Device Name: Ascension® Human Resurfacing Arthroplasty Regulation Number: 21 CFR 888.3690 Regulation Name: Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis Regulatory Class: Class II Product Code: HSD Dated: September 15, 2006 Received: September 25, 2006

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 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.

4

Page 2 - Mr. Glen Neally

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 its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

For Palo R
Mark N. Melkerson Dspvm

Division of General, Restorati and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

5

Indications For Use

510(K) Number: K. 062.861

Ascension® Humeral Resurfacing Arthroplasty Device Name:

Indications for Use:

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.
. Post-traumatic arthritis.
. Malunions of the humeral head.
. Acute fractures of the humeral head
. Patients with an intact or reparable rotator cuff.

Contraindications:

. Infection, sepsis, and osteomyelitis
. Osteoporosis
. Metabolic disorders which may impair bone formation
. Osteomalacia
. Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
. Revision procedures where other devices or treatments have failed.

Prescription Use	X	OR	Over-The-Counter Use
(Part 21 CFR 801Subpart B)			(Part 21 CFR 801Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)

(Division Sign-Off)
Division of General, Restorative,	Concurrence of CDRH, Office of Device Evaluation (ODE)
and Neurological Devices
510(k) Number	K06861