Humeris Shoulder: CE/MDD Class III, Fx Solutions

Regulatory status

as of registry sync 24 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDD EUDAMED	NumberB-03701037304600 Basic UDI-DI 03701037304600UDI-DI	Date16 Jun 2026Registered	StatusActive
United States	GUDID listing GUDID	Number03701037304600 UDI-DI	Date14 Dec 2017Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE 510(k) Substantially Equivalent · Traditional	NumberK163669	Date17 May 2017Cleared	StatusActive

Official records

EUDAMED public site Basic UDI-DI B-03701037304600 — open Devices and search for it
AccessGUDID record UDI-DI 03701037304600
FDA 510(k) database 510(k) number K163669

Across registries

3 registries list this device

EUDAMED Basic UDI-DI B-03701037304600 registered 16 Jun 2026 Active
FDA 510(k) K163669 decided 17 May 2017 Active
FDA GUDID UDI-DI 03701037304600 listed 14 Dec 2017 Listed

Timeline

3 dated events

17 May 2017 Cleared FDA 510(k) K163669
14 Dec 2017 Listed FDA GUDID 03701037304600
16 Jun 2026 Registered EUDAMED B-03701037304600

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

European Union CE/MDD Active
United States FDA 510(k) Active

Specification

EUDAMED · 510(k) · GUDID

Generic name: Coated shoulder humeral stem prosthesis
Model / Ref / Catalog: 316-0020

Primary DI / UDI-DI: 03701037304600
Basic UDI-DI: B-03701037304600
510(k) Number: K163669
FDA product code: PHX, HSD
EMDN code: P0901040201 Shoulder prostheses non modular stems
GMDN term: Coated shoulder humeral stem prosthesis

Device class: Class III EUDAMED
Class II 510(k)GUDID
Regulation: 21 CFR Part 888.3660 510(k)GUDID
888.3690 GUDID
EU registration type: Legacy device (under a directive)
EU market of registration: France
Advisory committee: Orthopedic
FDA decision: SESE Substantially Equivalent
GUDID distribution status: In Commercial Distribution

Truth per registry

3 sources · 1 field differs

Field	EUDAMED	510(k)	GUDID
Device class	EUDAMED Class III	510(k) Class II	GUDID Class II

Device class is stated on each registry's own scale: Class III in the EU (EUDAMED), Class II in the US (FDA 510(k), FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Humelock II Reversible Shoulder System K150488 13 Nov 2015 FDA record · FDA summary
Humelock Ii Cemented Shoulder System K123814 13 Aug 2013 FDA record · FDA summary
Aequalis Ascend Flex Shoulder System K122698 8 Jan 2013 FDA record · FDA summary

Cited by

Humeris® 135 Shoulder System K222936 7 Nov 2022 FDA record · FDA summary
AGILON XO Shoulder System K222482 28 Sep 2022 FDA record · FDA summary
FX V135 Shoulder Prosthesis K213117 7 Jun 2022 FDA record · FDA summary
Lateralized and Augmented Baseplates K210790 25 Aug 2021 FDA record · FDA summary
TiN Coated Humeral Head K191698 16 Jul 2020 FDA record · FDA summary
Humelock TiN Coated Glenosphere K191146 15 Jul 2020 FDA record · FDA summary
Humeral Cup Stability & Humeral Cup 135/145o Stability K193394 29 Apr 2020 FDA record · FDA summary
Glenoid Baseplate with Screw K192799 21 Feb 2020 FDA record · FDA summary
32mm Glenosphere and Humeral Cup K192206 8 Oct 2019 FDA record · FDA summary

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K163669

92 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K163669
		UDI-DI	Size and differences
Humeris Shoulder 106-3903 FX SOLUTIONS	106-3903 / 106-3903	03701037300558	Outer Diameter 39 mm Prescription: yes; Single use: yes	On the market
Humeris Shoulder 106-3905 FX SOLUTIONS	106-3905 / 106-3905	03701037300565	Outer Diameter 39 mm Prescription: yes; Single use: yes	On the market
Humeris Shoulder 106-4105 FX SOLUTIONS	106-4105 / 106-4105	03701037300589	Outer Diameter 41 mm Prescription: no; Single use: yes	On the market
Humeris Shoulder 106-4303 FX SOLUTIONS	106-4303 / 106-4303	03701037300596	Outer Diameter 43 mm Prescription: yes; Single use: yes	On the market
Humeris Shoulder 106-4305 FX SOLUTIONS	106-4305 / 106-4305	03701037300602	Outer Diameter 43 mm Prescription: yes; Single use: yes	On the market
Humeris Shoulder 106-5003 FX SOLUTIONS	106-5003 / 106-5003	03701037300657	Outer Diameter 50 mm Prescription: yes; Single use: yes	On the market
Humeris Shoulder 106-5005 FX SOLUTIONS	106-5005 / 106-5005	03701037300664	Outer Diameter 50 mm Prescription: yes; Single use: yes	On the market
Humeris Shoulder 106-5203 FX SOLUTIONS	106-5203 / 106-5203	03701037304204	Outer Diameter 52 mm Prescription: yes; Single use: yes	On the market
Humeris Shoulder 106-5205 FX SOLUTIONS	106-5205 / 106-5205	03701037304211	Outer Diameter 52 mm Prescription: yes; Single use: yes	On the market
Humeris Shoulder 106-5405 FX SOLUTIONS	106-5405 / 106-5405	03701037300688	Outer Diameter 54 mm Prescription: yes; Single use: yes	On the market
Humeris Shoulder 112-0030 FX SOLUTIONS	112-0030 / 112-0030	03701037300749	Angle 3 deg Prescription: yes; Single use: yes	No longer on the market
Humeris Shoulder 112-0033 FX SOLUTIONS	112-0033 / 112-0033	03701037300756	Angle 3 deg Prescription: yes; Single use: yes	No longer on the market
Humeris Shoulder 112-0035 FX SOLUTIONS	112-0035 / 112-0035	03701037300763	Angle 3 deg Prescription: yes; Single use: yes	No longer on the market
Humeris Shoulder 316-0008 FX SOLUTIONS	316-0008 / 316-0008	03701037301531	Prescription: yes; Single use: yes	On the market
Humeris Shoulder 316-0009 FX SOLUTIONS	316-0009 / 316-0009	03701037301548	Prescription: yes; Single use: yes	On the market
Humeris Shoulder 316-0013 FX SOLUTIONS	316-0013 / 316-0013	03701037301586	Prescription: yes; Single use: yes	On the market
Humeris Shoulder 316-0014 FX SOLUTIONS	316-0014 / 316-0014	03701037301593	Prescription: yes; Single use: yes	On the market
Humeris Shoulder 316-0015 FX SOLUTIONS	316-0015 / 316-0015	03701037301609	Prescription: yes; Single use: yes	On the market
Humeris Shoulder 316-0016 FX SOLUTIONS	316-0016 / 316-0016	03701037303689	Prescription: yes; Single use: yes	On the market
Humeris Shoulder 316-0017 FX SOLUTIONS	316-0017 / 316-0017	03701037304570	Prescription: yes; Single use: yes	No longer on the market
Humeris Shoulder 316-0019 FX SOLUTIONS	316-0019 / 316-0019	03701037304594	Prescription: yes; Single use: yes	No longer on the market
Humeris Shoulder 316-0106 FX SOLUTIONS	316-0106 / 316-0106	03701037303214	Prescription: yes; Single use: yes	No longer on the market
Humeris Shoulder 316-0107 FX SOLUTIONS	316-0107 / 316-0107	03701037303221	Prescription: yes; Single use: yes	No longer on the market
Humeris Shoulder 316-0109 FX SOLUTIONS	316-0109 / 316-0109	03701037303245	Prescription: yes; Single use: yes	No longer on the market
Humeris Shoulder 316-0110 FX SOLUTIONS	316-0110 / 316-0110	03701037303252	Prescription: yes; Single use: yes	No longer on the market
Humeris Shoulder 316-0113 FX SOLUTIONS	316-0113 / 316-0113	03701037303283	Prescription: yes; Single use: yes	No longer on the market
Humeris Shoulder 316-0114 FX SOLUTIONS	316-0114 / 316-0114	03701037303290	Prescription: yes; Single use: yes	No longer on the market
Humeris Shoulder 400-1101 FX SOLUTIONS	400-1101 / 400-1101	03701037301692	Prescription: yes; Single use: yes	On the market
Humeris Shoulder 400-1102 FX SOLUTIONS	400-1102 / 400-1102	03701037301708	Prescription: yes; Single use: yes	On the market
Humeris Shoulder 902-1007 FX SOLUTIONS	902-1007 / 902-1007	03701037304433	Prescription: no; Single use: no	No longer on the market
Humeris Shoulder 902-1008 FX SOLUTIONS	902-1008 / 902-1008	03701037304440	Prescription: no; Single use: no	No longer on the market
Humeris Shoulder 902-1009 FX SOLUTIONS	902-1009 / 902-1009	03701037304457	Prescription: no; Single use: no	No longer on the market
Humeris Shoulder 902-1012 FX SOLUTIONS	902-1012 / 902-1012	03701037304488	Prescription: no; Single use: no	No longer on the market
Humeris Shoulder 902-1015 FX SOLUTIONS	902-1015 / 902-1015	03701037304518	Prescription: no; Single use: no	No longer on the market
Humeris Shoulder 902-1020 FX SOLUTIONS	902-1020 / 902-1020	03701037304563	Prescription: no; Single use: no	No longer on the market
Humeris Shoulder 902-3503 FX SOLUTIONS	902-3503 / 902-3503	03701037307113	Outer Diameter 35 mm Prescription: yes; Single use: no	No longer on the market
Humeris Shoulder 902-3903 FX SOLUTIONS	902-3903 / 902-3903	03701037304228	Prescription: no; Single use: no	On the market
Humeris Shoulder 902-4103 FX SOLUTIONS	902-4103 / 902-4103	03701037304242	Prescription: no; Single use: no	No longer on the market
Humeris Shoulder 902-4105 FX SOLUTIONS	902-4105 / 902-4105	03701037304259	Prescription: no; Single use: no	No longer on the market
Humeris Shoulder 902-4305 FX SOLUTIONS	902-4305 / 902-4305	03701037304273	Prescription: no; Single use: no	No longer on the market
Humeris Shoulder 902-4603 FX SOLUTIONS	902-4603 / 902-4603	03701037304280	Prescription: no; Single use: no	No longer on the market
Humeris Shoulder 902-4605 FX SOLUTIONS	902-4605 / 902-4605	03701037304297	Prescription: no; Single use: no	No longer on the market
Humeris Shoulder 902-4805 FX SOLUTIONS	902-4805 / 902-4805	03701037304310	Prescription: no; Single use: no	No longer on the market
Humeris Shoulder 902-5003 FX SOLUTIONS	902-5003 / 902-5003	03701037304327	Prescription: no; Single use: no	No longer on the market
Humeris Shoulder 902-5205 FX SOLUTIONS	902-5205 / 902-5205	03701037304358	Prescription: no; Single use: no	No longer on the market
Humeris Shoulder 902-5403 FX SOLUTIONS	902-5403 / 902-5403	03701037304365	Prescription: no; Single use: no	No longer on the market
Humeris Shoulder 911-1001 FX SOLUTIONS	911-1001 / 911-1001	03701037304389	Prescription: no; Single use: no	On the market
Humeris Shoulder 911-1004 FX SOLUTIONS	911-1004 / 911-1004	03701037304419	Prescription: no; Single use: no	On the market
Humeris Shoulder 931-1001 FX SOLUTIONS	931-1001 / 931-1001	03701037312445	Prescription: yes; Single use: no	On the market
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT 906-0023 FX SOLUTIONS	906-0023 / 906-0023	03701037312636	Prescription: yes; Single use: no	On the market

Similar devices in this category

Other devices filed under SHOULDER PROSTHESES NON MODULAR STEMS.

Properties

Supplied sterile
Single use
Implantable
Prescription use
Lot / batch number

Other properties (18, all answered No)

Humeris Shoulder

Regulatory status

Across registries

Timeline

Coverage

Specification

Truth per registry

Devices cleared under K163669

Similar devices in this category

Other devices from Fx Solutions

FX V135 Shoulder Prosthesis 951-5614

Humelock 903-4036

Humelock 903-4440

Orthopedic Manual Surgical Instrument 901-1003

Properties

Regulatory status

Across registries

Timeline

Coverage

Specification

Truth per registry

Related clearances

Cites

Cited by

Devices cleared under K163669

Similar devices in this category

Other devices from Fx Solutions

FX V135 Shoulder Prosthesis 951-5614

Humelock 903-4036

Humelock 903-4440

Orthopedic Manual Surgical Instrument 901-1003

Properties