← Product Code [PHX](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/PHX) · K223211 # INHANCETM Shoulder System – Humeral Stems and Stemless (K223211) _Depuy Ireland UC · PHX · Dec 2, 2022 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/PHX/K223211 ## Device Facts - **Applicant:** Depuy Ireland UC - **Product Code:** [PHX](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/PHX.md) - **Decision Date:** Dec 2, 2022 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3660 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The INHANCE SHOULDER SYSTEM with the humeral stemless anchor is intended for use in anatomic total shoulder replacement procedures to address the following: Osteoarthritis; Post-traumatic arthrosis; Focal avascular necrosis of the humeral head; Previous surgeries of the shoulder that do not compromise the fixation. The INHANCE SHOULDER SYSTEM with a humeral stem is intended for use in anatomic total or hemi-shoulder replacement procedures to address the following: Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis; Rheumatoid arthritis; Revision where other devices or treatments have failed; Correction of functional deformity; Fractures of the humeral head (with Short Humeral Stems); Fractures of the humeral head and proximal humerus, where other methods of treatment are deemed inadequate (with Standard or Long Stems); Difficult clinical management problems where other methods of treatment may not be inadequate. The INHANCE SHOULDER SYSTEM Reverse Total Shoulder with a humeral stem is indicated for primary, fracture or revision total reverse shoulder replacement procedures to address the following. The system is indicated for use in patients whose shoulder joint has a gross rotator cuff deficiency. The patient must be anatomically suited to receive the implants and a functional deltoid muscle is necessary. The system is also indicated for conversion from an anatomic to reverse shoulder prosthesis without the removal of a well-fixed INHANCE humeral stem. A severely painful, disabling, arthritic joint; Fractures of the humeral head (with Short Humeral Stems); Fractures of the humeral head and proximal humerus (with Standard or Long Stems); Revisions of previously failed shoulder joint replacements. ## Device Story The INHANCE Shoulder System is a modular orthopedic implant set for shoulder arthroplasty. Components include titanium alloy humeral stems, stemless anchors, offset taper adapters, shells, baseplates, and screws, paired with cobalt-chromium humeral heads or glenospheres and cross-linked, Vitamin E UHMWPE liners/glenoids. Used in clinical settings by orthopedic surgeons to replace damaged shoulder joints. The system functions as a semi-constrained or non-constrained prosthesis to restore joint function and reduce pain. The device is implanted via surgical procedure; fixation methods include cementless application for stems/anchors and cemented or screw-fixation for glenoid components. The system provides structural support and articulation for the shoulder joint, directly replacing diseased or fractured bone surfaces. Benefits include pain relief, restoration of joint mobility, and correction of functional deformities. This submission specifically addresses modifications to the additive manufacturing process (printing orientation and layer thickness) for stemmed humeral anchors. ## Clinical Evidence No clinical data. Substantial equivalence demonstrated via bench testing, including construct fatigue testing per ASTM F1378, and comparative analysis of geometry, biocompatibility, and material properties. ## Technological Characteristics Materials: Titanium alloy (stems, anchors, adapters, shells, baseplates, screws), Cobalt-chromium (heads, glenospheres), Cross-linked Vitamin E UHMWPE (liners, glenoids). Manufacturing: Additive manufacturing. Fixation: Cementless (stems, anchors, glenoid baseplates) or cemented (stems, glenoids). Standards: ASTM F1378 for fatigue testing. Connectivity: None. Sterilization: Not specified. ## Regulatory 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). ## Special Controls *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.” ## Predicate Devices - INHANCE Reverse Shoulder System ([K212737](/device/K212737.md)) - INHANCE Anatomic Shoulder System ([K202716](/device/K202716.md)) - INHANCE Stemless Anatomic Shoulder System ([K203108](/device/K203108.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ December 2, 2022 Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Depuy Ireland UC % Russ Parrott VP of Research and Development Ignite Orthopedics LLC 700 Park Avenue Suite F Winona Lake, Indiana 46590 Re: K223211 Trade/Device Name: INHANCETM Shoulder System - Humeral Stems and Stemless Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX, MBF, KWT, KWS, PKC, PAO, HSD Dated: October 14, 2022 Received: October 17, 2022 Dear Russ Parrott: 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 ffor 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpm/pmn.cfm identifies.combination product submissions. 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 {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Image /page/1/Picture/5 description: The image shows the name "Victoria A. Lilling -S" in a large, clear font. The text is positioned on the left side of the image. The background is a light blue color, with a watermark-like design in the background. Digitally signed by Victoria A. Lilling -S Date: 2022.12.02 15:24:38 -05'00' Victoria Lilling, M.D. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use #### 510(k) Number (if known) K223211 Device Name INHANCE™ Shoulder System - Humeral Stems and Stemless Anchors Indications for Use (Describe) Anatomic Total Shoulder or Hemi-Shoulder The INHANCE SHOULDER SYSTEM with the humeral stemless anchor is intended for use in anatomic total shoulder replacement procedures to address the following: - · Osteoarthritis - · Post-traumatic arthrosis - Focal avascular necrosis of the humeral head - · Previous surgeries of the shoulder that do not compromise the fixation The INHANCE SHOULDER SYSTEM with a humeral stem is intended for use in anatomic total or hemi-shoulder replacement procedures to address the following: - · Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. - · Rheumatoid arthritis. - · Revision where other devices or treatments have failed. - · Correction of functional deformity. - · Fractures of the humeral head (with Short Humeral Stems) - · Fractures of the humeral head and proximal humerus, where other methods of treatment are deemed inadequate (with Standard or Long Stems) - · Difficult clinical management problems where other methods of treatment may not be inadequate. #### Fixation Methods The humeral stems are intended for cementless use. The humeral stemless anchor is intended for cementless use. The glenoid is intended for cemented use only. #### Reverse Total Shoulder The INHANCE SHOULDER SYSTEM Reverse Total Shoulder with a humeral stem is indicated for primary, fracture or revision total reverse shoulder replacement procedures to address the following. The system is indicated for use in patients whose shoulder joint has a gross rotator cuff deficiency. The patient must be anatomically suited to receive the implants and a functional deltoid muscle is necessary. The system is also indicated for conversion from an anatomic to reverse shoulder prosthesis without the removal of a well-fixed INHANCE humeral stem. - · A severely painful, disabling, arthritic joint - · Fractures of the humeral head (with Short Humeral Stems) - · Fractures of the humeral head and proximal humerus (with Standard or Long Stems) - · Revisions of previously failed shoulder joint replacements #### Fixation Methods The humeral stem is intended for cementless use. The glenoid baseplate components are intended for cementless application with the addition of screw fixation. {3}------------------------------------------------ Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ Image /page/4/Picture/0 description: The image contains the logo for Ignite Orthopedics. The logo features a blue flame-like graphic on the left, followed by the word "IGNITE" in gray, sans-serif font. Below "IGNITE" is the word "ORTHOPEDICS" in a smaller, sans-serif font, also in gray. # 510(k) Summary Prepared: October 14, 2022 Submitter: Ignite Orthopedics LLC 700 Park Ave. Suite F Winona Lake, IN 46590 Russ Parrott Contact: Chief Technology Officer Phone: 574.527.2864 russ.parrott@igniteorthopedics.com INHANCETM Shoulder System - Humeral Stems and Stemless Proprietary Name: Anchors Common Name: Anatomic and Reverse Shoulder Arthroplasty System Classification: Shoulder joint metal/polymer semi-constrained cemented prosthesis; (21 CFR §888.3660); Class II Shoulder Joint, Metal/Polymer/Metal, Non-Constrained or Semi-Porous Coated, Uncemented Prosthesis Constrained. CFR (21 \$888.3670); Class II Prosthesis, Shoulder, Non-Constrained, Metal/Polymer, Cemented (21 CFR §888.3650); Class II Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Cemented (21 CFR \$888.3660); Class II Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented, (21 CFR \$888.3690); Class II Total Anatomic Shoulder, Uncemented Metaphyseal Prosthesis. Humeral Stem With No Diaphyseal Incursion, Semi-Constrained (21 CFR §888.3660); Class II Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented (21 CFR §888.3660); Class II {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Ignite Orthopedics. The logo features a blue flame-like graphic on the left, followed by the word "IGNITE" in gray, sans-serif font. Below "IGNITE" is the word "ORTHOPEDICS" in a smaller, sans-serif font, also in gray. | | Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis
(21 CFR §888.3690); Class II | |-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Codes: | PHX, MBF, KWT, KWS, PKC, PAO, HSD | | Predicate Device: | K212737 – (Primary) INHANCE Reverse Shoulder System, DePuy
Ireland UC | | | K202716 – INHANCE Anatomic Shoulder System; DePuy Ireland UC
(formerly Ignite Anatomic Shoulder System; Ignite Orthopedics LLC) | | | K203108 – INHANCE Stemless Anatomic Shoulder System; DePuy
Ireland UC (formerly Ignite Stemless Anatomic Shoulder System; Ignite
Orthopedics LLC) | ### Device Description: The INHANCE™SHOULDER SYSTEM with a humeral stemless anchor is intended for use in anatomic total shoulder replacement procedures. The INHANCE SHOULDER SYSTEM with a humeral stem is intended for use in anatomic total, reverse total, or hemi-shoulder replacement procedures. The Anatomic Total Shoulder Prosthesis consists of individually packaged implants: a metal humeral stem or humeral stemless anchor (titanium alloy), an offset taper adapter (titanium alloy), a humeral head (cobalt-chromium) in combination with a Cross-linked, Vitamin E Ultra High Molecular Weight Polyethylene (Cross-linked, VE UHMWPE) glenoid. The Reverse Total Shoulder Prosthesis consists of individually packaged implants: a metal humeral stem (titanium alloy), a shell (titanium alloy), a liner (Cross-linked, VE UHMWPE) in combination with a glenosphere (cobalt-chromium), baseplate (titanium alloy), peripheral screws (titanium alloy), peripheral posts (titanium alloy), and either a central screw (titanium alloy) or a central post (titanium alloy). The Anatomic Hemi-Shoulder Prosthesis consists of individually packaged implants: a metal humeral stem (titanium alloy) an offset taper adapter (titanium alloy), a humeral head (cobaltchromium) (no glenoid component associated). {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Ignite Orthopedics. The logo features a blue flame-like graphic on the left side. To the right of the graphic, the word "IGNITE" is written in a gray sans-serif font, and below that, the word "ORTHOPEDICS" is written in a smaller, similar font. #### Intended Use / Indications for Use: #### Anatomic Total Shoulder or Hemi-Shoulder The INHANCE SHOULDER SYSTEM with the humeral stemless anchor is intended for use in anatomic total shoulder replacement procedures to address the following: - · Osteoarthritis - Post-traumatic arthrosis - · Focal avascular necrosis of the humeral head - Previous surgeries of the shoulder that do not compromise the fixation The INHANCE SHOULDER SYSTEM with a humeral stem is intended for use in anatomic total or hemi-shoulder replacement procedures to address the following: - Non-inflammatory degenerative joint disease including osteoarthritis and avascular . necrosis. - Rheumatoid arthritis. - · Revision where other devices or treatments have failed. - · Correction of functional deformity. - · Fractures of the humeral head (with Short Humeral Stems) - Fractures of the humeral head and proximal humerus, where other methods of treatment are deemed inadequate (with Standard or Long Stems) · Difficult clinical management problems where other methods of treatment may not be suitable or may be inadequate. #### Fixation Methods The humeral stems are intended for cemented or cementless use. The humeral stemless anchor is intended for cementless use. The glenoid is intended for cemented use only. #### Reverse Total Shoulder #### The INHANCE SHOULDER SYSTEM Reverse Total Shoulder with a humeral stem is indicated for primary, fracture or revision total reverse shoulder replacement procedures to address the following. The system is indicated for use in patients whose shoulder joint has a gross rotator cuff deficiency. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The system is also indicated for conversion from an anatomic to reverse shoulder prosthesis without the removal of a well-fixed INHANCE humeral stem. - · A severely painful, disabling, arthritic joint - · Fractures of the humeral head (with Short Humeral Stems) - · Fractures of the humeral head and proximal humerus (with Standard or Long Stems) - · Revisions of previously failed shoulder joint replacements {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for Ignite Orthopedics. The logo features a blue flame-like graphic on the left side. To the right of the graphic is the word "IGNITE" in a sans-serif font, with the word "ORTHOPEDICS" in a smaller font below it. ### Fixation Methods The humeral stem is intended for cemented or cementless use. The glenoid baseplate components are intended for cementless application with the addition of screw fixation. ### Summary of Technologies/Substantial Equivalence: The subject INHANCE Shoulder System - Humeral Stems and Stemless Anchors has the same indications for use intended use, material, manufacturing method, sterilization, and packaging as the previously cleared devices in the INHANCE Anatomic Shoulder System (K202716), the INHANCE Stemless Anatomic Shoulder System (K203108), and the INHANCE Reverse Shoulder System (K212737). The difference between the subject and predicate device is in the printing orientation and layer thickness in the additive manufacturing process of the stemmed humeral anchors. The finished form (geometry and biocompatibility) of the device is unaffected. Modifications to the additive manufacturing process do not result in greater risks of device fracture/failure. Because of these similarities, the subject of this submission, the INHANCE Shoulder System - Humeral Stems and Stemless Anchors, is substantially equivalent to the predicate INHANCE Anatomic Shoulder System (K202716), INHANCE Stemless Anatomic Shoulder System (K203108), and INHANCE Reverse Shoulder System (K212737). {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for Ignite Orthopedics. The logo features a blue flame-like graphic on the left side. To the right of the graphic is the word "IGNITE" in a gray sans-serif font, with the word "ORTHOPEDICS" in a smaller font below it. # Non-Clinical Testing: The INHANCE™ Shoulder System Humeral Stems and Stemless Anchors were evaluated using well-established methods to demonstrate substantial equivalence to the predicate devices. The following evaluations were completed: ### Construct Fatigue Testing Construct fatigue testing was performed on the subject devices per the methods described in ASTM F1378. The test methods and acceptance criteria were the same as utilized for the predicate devices. The acceptance criteria were met, demonstrating substantial equivalence of the subject and predicate devices. ### Range of Motion (RoM) Evaluation The geometry of the subject and predicate devices are identical. Therefore, the subject devices do not represent a new worst-case for range of motion when compared to the predicate devices. ### Construct Loosening and Disassociation The geometry of the subject and predicate devices are identical. Therefore, the subject devices do not represent a new worst-case for construct loosening and disassociation when compared to the predicate devices. #### Biocompatibility Assessments The raw materials and contact materials used in the manufacture of the subject Humeral Stems and Stemless Anchors are identical to those used on implants cleared in the predicate device submissions. Therefore, the subject devices do not represent a new worst-case for biocompatibility when compared to the predicate devices. #### Porous Structure Characterization The porous structure used for the subject device is identical to the porous structure that was applied to the predicate devices. Therefore, further characterization was not required. # MRI Compatibility The geometry and magnetism of the materials of the subject and predicate devices are identical. Therefore, the subject devices do not represent a new worst-case for MRI compatibility when compared to the predicate devices. {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the logo for Ignite Orthopedics. The logo features a blue flame-like graphic on the left side. To the right of the graphic, the word "IGNITE" is written in a gray, sans-serif font, and below that, the word "ORTHOPEDICS" is written in a smaller, sans-serif font. # Shelf Life Evaluation The subject devices use the same material and sterile packaging as the predicate devices. Therefore, the subject devices do not represent a new worst-case for shelf life when compared to the predicate devices. ### Sterilization Validation The subject devices use the same material, manufacturing locations, and sterile packaging as the predicate devices. Therefore, the subject devices do not represent a new worst-case for sterility when compared to the predicate devices. ### Clinical Testing: Clinical testing was not necessary to demonstrate substantial equivalence of the INHANCE™ Shoulder System Humeral Stems and Stemless Anchors to the predicate devices. ### Conclusion: A comparison of the subject and predicate devices, including comparison of the intended use, technological characteristics, and non-clinical evaluations has demonstrated that the subject devices have a safety and effectiveness profile equivalent to that of the predicate devices. --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/PHX/K223211](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/PHX/K223211) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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