510(k) · Cleared
ClearedSmith & Nephew, Inc. Shoulder System Instruments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Cleared on Sep 7, 2012 as substantially equivalent to K955767 (Smith & Nephew Richards, Inc., 1996) and 6 other predicates after an 88-day review. Its family tree reaches back 8 generations to 1991.
- Decided
- Sep 7, 2012
- Review
- 88 days
- Class
- Class II
- Product code
- HSD
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 8 generations to K911686 (1991). 37 ancestors in all, the oldest K800494 (1980). No later device cites it as a predicate yet.
- Root · 8 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 7 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 6 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 5 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 4 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 3 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 2 generations backK053274 Anatomical Shoulder Inverse/ReverseZimmer GmbH · 2006 · Recalled
- 1 generation backK081016 Smith & Nephew, Inc., Promos Reverse Shoulder SystemSmith & Nephew, Inc. · 2008 · Recalled
- This deviceK121714 Smith & Nephew, Inc. Shoulder System InstrumentsSmith & Nephew, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −7 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −6 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −5 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −4 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −3 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −2 | K053274 | Anatomical Shoulder Inverse/Reverse | Zimmer GmbH | 2006 | 3 |
| −1 | K081016 | Smith & Nephew, Inc., Promos Reverse Shoulder System | Smith & Nephew, Inc. | 2008 | 2 |
| 0 (this device) | K121714 | Smith & Nephew, Inc. Shoulder System Instruments | Smith & Nephew, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 2 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 5 | 0 |
| 2000 | 1 | 0 |
| 2001 | 6 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HSD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HSD device
- #1 K191433 AGILON® XO Shoulder Replacement Systemscore 13.8 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (7)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K955767 | Cofied Modular Shoulder SystemSummary page 1…thopaedics/87 Predicate Devices: Cofield Shoulder System cemented (K1955767); Cofield Shoulder System (K855183); Cofield Modular Shoulder System (K955767); Cofield Eccentric and Lateral offset Humeral Heads (K00356.6); PROMOS Shoulder (K032126); PLUS PROMOS M… | 1996 |
| * | K855183 | Cofield Shoulder SystemSummary page 1…ed prosthesis Device Class: Class 11 Panel Code: Orthopaedics/87 Predicate Devices: Cofield Shoulder System cemented (K1955767); Cofield Shoulder System (K855183); Cofield Modular Shoulder System (K955767); Cofield Eccentric and Lateral offset Humeral Heads (K00356.6);… | 1986 |
| * | K003566 | Cofield Eccentric and Lateral Offset Humeral Heads | 2001 |
| * | K032126 | Promos ShoulderSummary page 1…lder System (K855183); Cofield Modular Shoulder System (K955767); Cofield Eccentric and Lateral offset Humeral Heads (K00356.6); PROMOS Shoulder (K032126); PLUS PROMOS Modular Shoulder System (K063578); Cofield2 Total Shoulder System (K(070565); PROMOS Revers… | 2004 |
| * | K063578 | Promos Modular Shoulder SystemSummary page 1…System (K955767); Cofield Eccentric and Lateral offset Humeral Heads (K00356.6); PROMOS Shoulder (K032126); PLUS PROMOS Modular Shoulder System (K063578); Cofield2 Total Shoulder System (K(070565); PROMOS Reverse Shoulder System (K(081 016) Device Description Subje… | 2007 |
| * | K070565 | Cofield Total Shoulder SystemSummary page 1…eral offset Humeral Heads (K00356.6); PROMOS Shoulder (K032126); PLUS PROMOS Modular Shoulder System (K063578); Cofield2 Total Shoulder System (K(070565); PROMOS Reverse Shoulder System (K(081 016) Device Description Subject of this Traditional 510(k) Premarket Notificatio… | 2007 |
| * | K081016 | Smith & Nephew, Inc., Promos Reverse Shoulder System | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 5 companies; a new generation was cleared every 2.6 years on median.
- 10 of the 37 ancestors have a recall of any class.
- 4 other devices also cite its predicate K955767.
How does its category compare?
All HSD devicesHSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · HSD
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · HSD
145in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HSD
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HSD
757in 2025
MAUDE reports naming product code HSD, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 4 | 72 | 0 | 128 |
| 2008 | 3 | 92 | 2 | 259 |
| 2009 | 0 | — | 2 | 156 |
| 2010 | 0 | — | 0 | 225 |
| 2011 | 2 | — | 0 | 241 |
| 2012 | 2 | — | 0 | 254 |
| 2013 | 4 | 218 | 0 | 288 |
| 2014 | 1 | — | 0 | 434 |
| 2015 | 0 | — | 0 | 574 |
| 2016 | 3 | 145 | 0 | 784 |
| 2017 | 0 | — | 3 | 985 |
| 2018 | 1 | — | 1 | 649 |
| 2019 | 0 | — | 0 | 830 |
| 2020 | 2 | — | 1 | 658 |
| 2021 | 0 | — | 0 | 573 |
| 2022 | 1 | — | 0 | 508 |
| 2023 | 0 | — | 0 | 586 |
| 2024 | 1 | — | 0 | 693 |
| 2025 | 0 | — | 0 | 757 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Smith &Nephew Cofield2 Shoulder Instruments are accessory devices and are intended to be used to assist in the implantation of Smith &Nephew Cofield2 Shoulder Systems and their cleared Indications for Use. Indications for Shoulder Replacement Proximal Humeral Prosthesis 1. Complex, acute fractures or fracture-dislocations of the humeral head (e.g., trauma-three and four-part injuries in the Neer classification, or head-splitting, or head impression…
Read the full statement (589 words)
Smith &Nephew Cofield2 Shoulder Instruments are accessory devices and are intended to be used to assist in the implantation of Smith &Nephew Cofield2 Shoulder Systems and their cleared Indications for Use.
Indications for Shoulder Replacement
Proximal Humeral Prosthesis
1. Complex, acute fractures or fracture-dislocations of the humeral head (e.g., trauma-three and four-part injuries in the Neer classification, or head-splitting, or head impression fractures).
2. Complex, chronic fractures or fracture-dislocations of the humeral head with malunion, nonunion of a small osteoporotic head fragment, or chronic dislocation with loss of humeral head cartilage, or large impression fractures.
3. Avascular necrosis with intact glenoid cartilage.
4. Selected patients with arthritis who do not have adequate scapular bone to support a glenoid component or who must engage in moderately heavy activties.
Total Shoulder Arthroolastv
Severe destruction of the glenohumeral articular surfaces with intractable chronic pain in rheumatoid arthritis, osteoarthritis, traumatic arthritis, cuff tear arthroplasty, ancient septic arthritis, avascular necrosis with secondary glenoid changes, radiation necrosis, and other failed reconstructive procedures
The Cofield2 Shoulder System includes humeral devices which are intended for use with or without bone cement and are single use devices. Cofield2 Shoulder System glenoid components are intended for use only with bone cement and are single use devices.
Smith &Nephew Cofield Shoulder Instruments are accessory devices and are intended to be used to assist in the implantation of Smith &Nephew Cofield Shoulder Systems and their cleared indications for Use.
Indications for Shoulder Replacement
Proximal Humeral Prosthesis
1. Complex, acute fractures or fracture-dislocations of the humeral head (e.g., the four-part injuries in the Neer classification, or head-spitting, or head impression fractures).
2. Complex, chronic fractures or fracture-dislocations of the humeral head with malunion, nonunion of a small osteoporotic head fragment, or chronic dislocation with loss of humeral head cartilage, or large impression fractures.
3. Avascular necrosis with intact glenoid cartilage.
4. Selected patients with arthritis who do not have adequate scapular bone to support a glenoid component or who must engage in moderately heavy activities.
Total Shoulder Arthroolastv
Severe destruction of the glenohumeral articular surfaces with intractable chronic pain in rheumatoid arthritis, osteoarthritis, traumatic arthritis, cuff tear arthroplasty, ancient septic arthritis, avascular necrosis with secondary glenoid changes, radiation necrosis, and other failed reconstructive procedures
The Cofield Shoulder System contains devices which are intended only for use with bone cement and are single use devices.
Smith & Nephew Shoulder Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Shoulder Systems and their cleared Indications for Use.
The PROMOS Modular Shoulder System (Standard) is indicated for:
* Advanced wear of the shoulder joint due to degenerative, post-traumatic or inflammatory arthritis
* Avascular necrosis of the humeral head
* Complex fractures of the proximal humerus
* Functional impairment especially in the case of post-traumatic loss of the joint configuration
The humeral stem and body components are intended for cementless use.
The glenoid component is for use with bone cement only.
The PROMOS Modular Shoulder System (Reverse) is indicated for the following:
* The PROMOS Reverse Shoulder is indicated for use in a grossly deficient rotator cuff joint with severe arthropathy or a previous failed joint replacement with a grossly deficient rotator cuff joint
* The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.
The humeral stem and body components are intended for cementless use.
The glenoid baseplate is intended for cementless application with the addition of screws for fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121714 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121714: Smith & Nephew, Inc. Shoulder System Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121714
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026