ROSA® Shoulder System

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or if there is a change or modification in a device that could significantly affect the safety or effectiveness of
the device, e.g., a significant change or modification in design, material, chemical composition, energy
source, or manufacturing process. Accordingly, if deviations from the established PCCP result in a major
change or modification in the intended use of the device, or result in a change or modification in the device
that could significantly affect the safety or effectiveness of the device, then a new premarket notification
would be required consistent with section 515C(b)(1) of the Act and 21 CFR 807.81(a)(3). Failure to submit
such a premarket submission would constitute adulteration and misbranding under sections 501(f)(1)(B) and
502(o) of the Act, respectively.

Additional information about changes that may require a new premarket notification are provided in the FDA
guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software
Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality Management System Regulation
(QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls),
ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485
clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review,
the QMSR requires device manufacturers to review and approve changes to device design and production
(ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical
Device File (ISO 13485 clause 4.2.3).

Please be advised that FDA's issuance of a

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or if there is a change or modification in a device that could significantly affect the safety or effectiveness of
the device, e.g., a significant change or modification in design, material, chemical composition, energy
source, or manufacturing process. Accordingly, if deviations from the established PCCP result in a major
change or modification in the intended use of the device, or result in a change or modification in the device
that could significantly affect the safety or effectiveness of the device, then a new premarket notification
would be required consistent with section 515C(b)(1) of the Act and 21 CFR 807.81(a)(3). Failure to submit
such a premarket submission would constitute adulteration and misbranding under sections 501(f)(1)(B) and
502(o) of the Act, respectively.

Additional information about changes that may require a new premarket notification are provided in the FDA
guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software
Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality Management System Regulation
(QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls),
ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485
clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review,
the QMSR requires device manufacturers to review and approve changes to device design and production
(ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical
Device File (ISO 13485 clause 4.2.3).

Please be advised that FDA's issuance of a