510(k) · Cleared
ClearedBone Screws dia. 5,0 mm
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lima Corporate S.P.A. · PHX Shoulder Prosthesis, Reverse Configuration
Cleared on Jul 12, 2021 as substantially equivalent to K191746 (Lima Corporate S.P.A., 2019) and 2 other predicates after a 124-day review. Its family tree reaches back 16 generations to 1991. 1 of the 154 devices in its family, counting itself, has a Class I recall. 8 later devices descend from it.
- Decided
- Jul 12, 2021
- Review
- 124 days
- Class
- Class II
- Product code
- PHX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 16 generations to K911686 (1991). 145 ancestors in all, the oldest K790987 (1979). 8 later devices descend from it, 1 citing it directly. 1 of the 154 devices in this family, counting this one, has a Class I recall.
- Root · 16 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 12 generations between
- 3 generations backK122698 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · Recalled
- 2 generations backK191963 SMR Finned Short StemsLima Corporate S.P.A. · 2019
- 1 generation backK200171 SMR TT Augmented Glenoid SystemLima Corporate S.P.A. · 2020
- This deviceK210717 Bone Screws dia. 5,0 mmLima Corporate S.P.A. · 2021
- Descendant · cites it directly · 7 of its ownK220792 SMR Reverse LinerLima Corporate S.P.A. · 2022
- Descendant · 2 generations on · 3 of its ownK223876 SMR Shoulder SystemLima Corporate S.P.A. · 2023
- Descendant · 2 generations on · 2 of its ownK222427 PRIMA TT GlenoidLima Corporate S.P.A. · 2022 · Recalled
- Descendant · 3 generations on · 1 of its ownK243826 SMR Reverse HP Shoulder SystemLima Corporate S.P.A. · 2025
- Descendant · 3 generations on · 1 of its ownK233712 PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A. · 2024
Show all 16 generations
- Root · 16 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 15 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 14 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 13 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 12 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 11 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 10 generations backK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
- 9 generations backK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
- 8 generations backK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
- 7 generations backK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled
- 6 generations backK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
- 5 generations backK110599 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- 4 generations backK112615 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- 3 generations backK122698 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · Recalled
- 2 generations backK191963 SMR Finned Short StemsLima Corporate S.P.A. · 2019
- 1 generation backK200171 SMR TT Augmented Glenoid SystemLima Corporate S.P.A. · 2020
- This deviceK210717 Bone Screws dia. 5,0 mmLima Corporate S.P.A. · 2021
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K080642 Comprehensive Reverse Shoulder3 generations back · 2008
Most influential descendants
Showing 5 of 8 · See all- K220792SMR Reverse LinerLima Corporate S.P.A. · 2022 · cites it directly7descendants
- K223876SMR Shoulder SystemLima Corporate S.P.A. · 2023 · 2 generations on3descendants
- K222427PRIMA TT GlenoidLima Corporate S.P.A. · 2022 · 2 generations on2descendants
- K243826SMR Reverse HP Shoulder SystemLima Corporate S.P.A. · 2025 · 3 generations on1descendant
- K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A. · 2024 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −15 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −14 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −13 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −12 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −11 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −10 | K052906 | Zimmer Trabecular Metal Reverse Shoulder System | Zimmer, Inc. | 2005 | 12 |
| −9 | K060704 | Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MM | Zimmer, Inc. | 2006 | 10 |
| −8 | K063569 | Equinoxe Reverse Shoulder System | Exactech, Inc. | 2007 | 13 |
| −7 | K073688 | Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking Screw | Exactech, Inc. | 2008 | 1 |
| −6 | K080642 | Comprehensive Reverse Shoulder | Biomet, Inc. | 2008 | Class I |
| −5 | K110599 | Aequalis Ascend Modular Reverse Shoulder System | Tornier, Inc. | 2011 | — |
| −4 | K112615 | Aequalis Ascend Modular Reverse Shoulder System | Tornier, Inc. | 2011 | — |
| −3 | K122698 | Aequalis Ascend Flex Shoulder System | Tornier S.A.S. | 2013 | 2 |
| −2 | K191963 | SMR Finned Short Stems | Lima Corporate S.P.A. | 2019 | — |
| −1 | K200171 | SMR TT Augmented Glenoid System | Lima Corporate S.P.A. | 2020 | — |
| 0 (this device) | K210717 | Bone Screws dia. 5,0 mm | Lima Corporate S.P.A. | 2021 | — |
| +1 | K220792 | SMR Reverse Liner | Lima Corporate S.P.A. | 2022 | — |
| +2 | K223876 | SMR Shoulder System | Lima Corporate S.P.A. | 2023 | — |
| +2 | K222427 | PRIMA TT Glenoid | Lima Corporate S.P.A. | 2022 | 3 |
| +3 | K243826 | SMR Reverse HP Shoulder System | Lima Corporate S.P.A. | 2025 | — |
| +3 | K233712 | PRIMA Humeral System; PRIMA TT Glenoid | Lima Corporate S.P.A. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 2 | 0 |
| 1986 | 1 | 0 |
| 1987 | 5 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 6 | 0 |
| 1995 | 2 | 0 |
| 1996 | 8 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 6 | 0 |
| 2000 | 10 | 0 |
| 2001 | 8 | 0 |
| 2002 | 3 | 0 |
| 2003 | 6 | 0 |
| 2004 | 4 | 0 |
| 2005 | 7 | 0 |
| 2006 | 11 | 0 |
| 2007 | 6 | 0 |
| 2008 | 8 | 0 |
| 2009 | 1 | 0 |
| 2010 | 4 | 0 |
| 2011 | 6 | 0 |
| 2012 | 6 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 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.
1 device in this family has a Class I recall. 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 PHX device
- #1 K212737 INHANCE™ Reverse Shoulder Systemscore 28.4 · 15 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K191746 | SMR TT Augmented Glenoid SystemSummary page 5…d per 21 CFR 888.3650 Description: Bone Screws are characterized by a 5,0 mm diameter (new device) and they are used in combination with SMR TT Augmented 360 Baseplate (K191746/K200171) to fix the baseplate to the glenoid bone. The SMR TT Augmented 360 Baseplate is a metal back glenoid component coupled… | 2019 |
| * | K200171 | SMR TT Augmented Glenoid SystemSummary page 5…CFR 888.3650 Description: Bone Screws are characterized by a 5,0 mm diameter (new device) and they are used in combination with SMR TT Augmented 360 Baseplate (K191746/K200171) to fix the baseplate to the glenoid bone. The SMR TT Augmented 360 Baseplate is a metal back glenoid component coupled to a peg… | 2020 |
| * | K161742 | Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed GlenoidSummary page 8…Page 4 of 4 Predicate Devices: • SMR TT Augmented Glenoid System (Limacorporate, K191746/K200171) • Tornier 5.0mm peripheral screw (K161742) Summary of technology comparison: Bone Screws dia. 5,0 mm are identical in material, manufacturing process, packaging, steriliz… | 2016 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K220792 | SMR Reverse Liner | 2022 | 7 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K080642Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 30 years and passes through 9 companies; a new generation was cleared every 1.0 years on median.
- 42 of the 145 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K220792 (Lima Corporate S.P.A., 2022) has gone furthest, with 7 descendants of its own.
- 1 other device also cites its predicate K191746.
How does its category compare?
All PHX devicesPHX Shoulder Prosthesis, Reverse Configuration: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · PHX
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PHX
72in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PHX
3in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PHX
2,848in 2025
MAUDE reports naming product code PHX, 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 | 5 | 97 | 0 | 0 |
| 2008 | 6 | 79 | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 8 | 124 | 0 | 0 |
| 2011 | 12 | 94 | 0 | 0 |
| 2012 | 12 | 114 | 0 | 0 |
| 2013 | 8 | 143 | 0 | 0 |
| 2014 | 12 | 110 | 0 | 0 |
| 2015 | 4 | 206 | 2 | 14 |
| 2016 | 4 | 132 | 0 | 5 |
| 2017 | 11 | 141 | 0 | 25 |
| 2018 | 14 | 127 | 1 | 323 |
| 2019 | 9 | 144 | 3 | 504 |
| 2020 | 13 | 143 | 3 | 986 |
| 2021 | 21 | 143 | 8 | 1,404 |
| 2022 | 9 | 198 | 0 | 1,342 |
| 2023 | 9 | 154 | 7 | 1,401 |
| 2024 | 9 | 139 | 1 | 2,142 |
| 2025 | 9 | 72 | 3 | 2,848 |
| 2026 | 18 | 130 | 7 | — |
What is it indicated for?
The SMR Shoulder System is intended for partial or total, primary or revision shoulder joint replacement. The SMR Anatomic Shoulder System is indicated for partial or total, primary or revision shoulder joint replacement in patients suffering from disability due to: • non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis; • inflammatory degenerative joint disease such as rheumatoid arthritis; • treatment of acute…
Read the full statement (346 words)
The SMR Shoulder System is intended for partial or total, primary or revision shoulder joint replacement.
The SMR Anatomic Shoulder System is indicated for partial or total, primary or revision shoulder joint replacement in patients suffering from disability due to:
• non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
• inflammatory degenerative joint disease such as rheumatoid arthritis;
• treatment of acute fractures of the humeral head that cannot be treated with other fracture fixation methods;
• revision of a failed primary implant;
• cuff tear arthropathy (CTA Heads only);
• glenoid arthrosis without excessive glenoid bone loss: A1, A2 and B1 according to Walch classification (SMR TT Hybrid Glenoid only).
The SMR Reverse Shoulder System is indicated for primary, fracture or revision total shoulder replacement in a grossly rotator cuff deficient joint with severe arthropathy (disabled shoulder). 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 SMR TT Hybrid Glenoid Reverse Baseplate must not be used in cases of excessive glenoid bone loss and/or when bone graft is needed.
The Modular SMR Shoulder System allows the assembly of components in various humeral and glenoid constructs. The constructs are intended for cemented and uncemented use as specified in the following table.
In the Anatomic shoulder the humeral construct consists of the humeral stem, the humeral body, the adaptor taper and the humeral head. In the Reverse shoulder the humeral construct consists of the humeral stem, the reverse humeral body and the reverse liner. On the humeral side the fixation of the humeral stem determines if the construct is cemented or uncemented.
The Anatomic glenoid construct consists of an all polyethylene glenoid, a polyethylene glenoid with metal peg or a metal back assembled with a liner; the Reverse glenoid consists of a metal back/connector/glenosphere construct or of a peg/baseplate/glenosphere construct.
On the glenoid side, the fixation of the all polyethylene glenoid, the polyethylene glenoid with metal peg or the metal back determines if the construct is cemented or uncemented.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210717 · printed Nov 5, 2026
Cite this page
510(k) Report. “K210717: Bone Screws dia. 5,0 mm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K210717
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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