510(k) · Cleared
Recalled · Class II · 2026Augment Off-Axis Instrument System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fix Surgical · PHX Shoulder Prosthesis, Reverse Configuration
Cleared on May 15, 2024 as substantially equivalent to K233148 (Fix Surgical, 2024) after a 28-day review. Its family tree reaches back 15 generations to 1991. 1 of the 94 devices in its family, counting itself, has a Class I recall. 1 later device descends from it. It has been recalled 5 times.
- Decided
- May 15, 2024
- Review
- 28 days
- Class
- Class II
- Product code
- PHX
- Recalls
- 5
- Predicates
- 1
Its longest line of descent runs back 15 generations to K911686 (1991). 92 ancestors in all, the oldest K790987 (1979). 1 later device descends from it, 1 citing it directly. 1 of the 94 devices in this family, counting this one, has a Class I recall.
- Root · 15 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 11 generations between
- 3 generations backK131353 Comprehensive Reverse Shoulder - Titanium GlenosphereBiomet Manufacturing Corp · 2013
- 2 generations backK193373 Comprehensive® Reverse ShoulderBiomet, Inc. · 2020 · Recalled
- 1 generation backK233148 Augment Off-Axis Instrument SystemFix Surgical · 2024
- This deviceK241043 Augment Off-Axis Instrument SystemFix Surgical · 2024
- Descendant · cites it directly · 0 of its ownK261683 Augment Off-Axis Instrument SystemZimmer, Inc. · 2026
Show all 15 generations
- Root · 15 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 14 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 13 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 12 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 11 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 10 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 9 generations backK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
- 8 generations backK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
- 7 generations backK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
- 6 generations backK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled
- 5 generations backK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
- 4 generations backK093803 Bio-Modular Reverse SholderBiomet Manufacturing Corp · 2010
- 3 generations backK131353 Comprehensive Reverse Shoulder - Titanium GlenosphereBiomet Manufacturing Corp · 2013
- 2 generations backK193373 Comprehensive® Reverse ShoulderBiomet, Inc. · 2020 · Recalled
- 1 generation backK233148 Augment Off-Axis Instrument SystemFix Surgical · 2024
- This deviceK241043 Augment Off-Axis Instrument SystemFix Surgical · 2024
Class I recalls in this family
- K080642 Comprehensive Reverse Shoulder2 generations back · 2008
Most influential descendants
Showing 1 of 1 · See all- K261683Augment Off-Axis Instrument SystemZimmer, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −14 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −13 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −12 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −11 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −10 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −9 | K052906 | Zimmer Trabecular Metal Reverse Shoulder System | Zimmer, Inc. | 2005 | 12 |
| −8 | K060704 | Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MM | Zimmer, Inc. | 2006 | 10 |
| −7 | K063569 | Equinoxe Reverse Shoulder System | Exactech, Inc. | 2007 | 13 |
| −6 | K073688 | Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking Screw | Exactech, Inc. | 2008 | 1 |
| −5 | K080642 | Comprehensive Reverse Shoulder | Biomet, Inc. | 2008 | Class I |
| −4 | K093803 | Bio-Modular Reverse Sholder | Biomet Manufacturing Corp | 2010 | — |
| −3 | K131353 | Comprehensive Reverse Shoulder - Titanium Glenosphere | Biomet Manufacturing Corp | 2013 | — |
| −2 | K193373 | Comprehensive® Reverse Shoulder | Biomet, Inc. | 2020 | 2 |
| −1 | K233148 | Augment Off-Axis Instrument System | Fix Surgical | 2024 | — |
| 0 (this device) | K241043 | Augment Off-Axis Instrument System | Fix Surgical | 2024 | — |
| +1 | K261683 | Augment Off-Axis Instrument System | Zimmer, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 2 | 0 |
| 1986 | 1 | 0 |
| 1987 | 2 | 0 |
| 1989 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 6 | 0 |
| 1995 | 3 | 0 |
| 1996 | 6 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 4 | 0 |
| 2000 | 5 | 0 |
| 2001 | 3 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 4 | 0 |
| 2005 | 8 | 0 |
| 2006 | 5 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (1)
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 |
|---|---|---|---|
| * | K233148 | Augment Off-Axis Instrument SystemSummary page 4…hesis Device Common Name: Shoulder Prosthesis Device Class: II Reviewing Panel: Orthopedic Primary Predicate Device: K233148 – Augment Off-Axis Instrument System Device Description: The Augment Off-Axis Instrument System consists of specialized instrum… | 2024 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K261683 | Augment Off-Axis Instrument System | 2026 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 20, 2026 | Class II | Z-2528-2026 | Under Investigation by firm | Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage. |
| May 20, 2026 | Class II | Z-2531-2026 | Under Investigation by firm | Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage. |
| May 20, 2026 | Class II | Z-2530-2026 | Under Investigation by firm | Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage. |
| May 20, 2026 | Class II | Z-2529-2026 | Under Investigation by firm | Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage. |
| May 20, 2026 | Class II | Z-2527-2026 | Under Investigation by firm | Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage. |
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 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 33 years and passes through 8 companies; a new generation was cleared every 1.0 years on median.
- 32 of the 92 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K261683 (Zimmer, Inc., 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All PHX devicesPHX Shoulder Prosthesis, Reverse Configuration: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 Augment Off-Axis Instrument System consists of specialized instruments intended to prepare
anatomy prior to implantation of Comprehensive® Reverse Shoulder System components in reverse
total shoulder arthroplasty procedures or Alliance® Augmented Glenoid System components in
anatomic total shoulder arthroplasty procedures in accordance with their respective cleared
indications for use and contraindications.
The instruments for this system are specifically indicated for use with the Comprehensive ® Reverse
Shoulder System (K193373) or the Alliance® Augmented Glenoid System (K193180).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241043 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241043: Augment Off-Axis Instrument System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241043
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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