510(k) Report

510(k) · Cleared

Cleared

AltiVate Anatomic to Reverse Conversion Module

K173073510(k) TraditionalCleared Dec 26, 201788-day reviewClass II21 CFR 888.3660

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Encore Medical L.P. · PHX Shoulder Prosthesis, Reverse Configuration

Cleared on Dec 26, 2017 as substantially equivalent to K162024 (Encore Medical L.P., 2016) and 3 other predicates after an 88-day review. Its family tree reaches back 13 generations to 1991. 3 later devices descend from it.

Decided
Dec 26, 2017
Review
88 days
Class
Class II
Product code
PHX
Recalls
None
Predicates
4

Its longest line of descent runs back 13 generations to K911686 (1991). 112 ancestors in all, the oldest K790987 (1979). 3 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2011: 3 other ancestors2009: 1 other ancestor2005: 6 other ancestors2013: 2 other ancestors2012: 2 other ancestors2008: 3 other ancestors2010: 2 other ancestors2007: 4 other ancestors2006: 7 other ancestors2003: 8 other ancestors2002: 2 other ancestors1999: 4 other ancestors2004: 4 other ancestors2001: 6 other ancestors2000: 7 other ancestors1998: 7 other ancestors1995: 6 other ancestors1994: 3 other ancestors1993: 3 other ancestors1992: 5 other ancestors1987: 3 other ancestors1996: 4 other ancestors1980: 2 other ancestors1997: 1 other ancestor1989: 1 other ancestor1986: 1 other ancestor1979: 1 other ancestor1981: 1 other ancestor2022: 1 descendant cleared2025: 1 descendant cleared2024: 1 descendant clearedK911686 · Global Total Shoulder, Uncement Humeral Hemi-Shoul · Depuy, Inc. · 1991×2: 2 generations cleared close together, K984541 (1999), K992065 (1999) ×3: 3 generations cleared close together, K021478 (2003), K030941 (2004), K041873 (2004) K050316 · Aequalis Reversed Shoulder Prosthesis · Tornier · 2005K061439 · Aequalis Reversed Prosthesis · Tornier · 2006K071948 · Aequalis Reversed Adapter · Tornier · 2007K082120 · Aequalis Reversed Fracture Shoulder Prothesis · Tornier · 2008K103208 · Reverse Shoulder Prosthesis Monoblock Stem · Encore Medical L.P. · 2011K140904 · RSP Monoblock Stem with P2 Coating, Size 6 · Encore Medical L.P. · 2014K162024 · AltiVate Anatomic Shoulder System · Encore Medical L.P. · 2016 · recalled19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 4 other ancestors3 generations back: 5 other ancestors4 generations back: 11 other ancestors5 generations back: 31 other ancestors6 generations back: 16 other ancestors7 generations back: 10 other ancestors8 generations back: 16 other ancestors9 generations back: 3 other ancestors 1 generation forward: 1 descendant2 generations forward: 2 descendants K162024 · AltiVate Anatomic Shoulder System · Encore Medical L.P. · 2016 · recalledK140904 · RSP Monoblock Stem with P2 Coating, Size 6 · Encore Medical L.P. · 2014K103208 · Reverse Shoulder Prosthesis Monoblock Stem · Encore Medical L.P. · 2011K082120 · Aequalis Reversed Fracture Shoulder Prothesis · Tornier · 2008K071948 · Aequalis Reversed Adapter · Tornier · 2007K061439 · Aequalis Reversed Prosthesis · Tornier · 2006K050316 · Aequalis Reversed Shoulder Prosthesis · Tornier · 2005K041873 · Aequalis Reversed Shoulder Prosthesis · Tornier · 2004K030941 · Aequalis Reversed Shoulder Prosthesis · Tornier · 2004K021478 · Delta Shoulder · Depuy, Inc. · 2003K992065 · Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage Eccentric Head · DePuy Orthopaedics, Inc. · 1999K984541 · Global FX Humeral Stem, Global Advantage Humeral Head · DePuy Orthopaedics, Inc. · 1999K911686 · Global Total Shoulder, Uncement Humeral Hemi-Shoul · Depuy, Inc. · 1991−10−50
  1. Root · 13 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
  2. 9 generations between
  3. 3 generations backK103208 Reverse Shoulder Prosthesis Monoblock StemEncore Medical L.P. · 2011
  4. 2 generations backK140904 RSP Monoblock Stem with P2 Coating, Size 6Encore Medical L.P. · 2014
  5. 1 generation backK162024 AltiVate Anatomic Shoulder SystemEncore Medical L.P. · 2016 · Recalled
  6. This deviceK173073 AltiVate Anatomic to Reverse Conversion ModuleEncore Medical L.P. · 2017
  7. Descendant · cites it directly · 2 of its ownK212800 PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A. · 2022 · Recalled
  8. Descendant · 2 generations on · 1 of its ownK233712 PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A. · 2024
  9. Descendant · 2 generations on · 0 of its ownK251184 AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder…Encore Medical L.P. · 2025
Show all 13 generations
  1. Root · 13 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
  2. 12 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
  3. 11 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
  4. 10 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
  5. 9 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
  6. 8 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
  7. 7 generations backK050316 Aequalis Reversed Shoulder ProsthesisTornier · 2005
  8. 6 generations backK061439 Aequalis Reversed ProsthesisTornier · 2006
  9. 5 generations backK071948 Aequalis Reversed AdapterTornier · 2007
  10. 4 generations backK082120 Aequalis Reversed Fracture Shoulder ProthesisTornier · 2008
  11. 3 generations backK103208 Reverse Shoulder Prosthesis Monoblock StemEncore Medical L.P. · 2011
  12. 2 generations backK140904 RSP Monoblock Stem with P2 Coating, Size 6Encore Medical L.P. · 2014
  13. 1 generation backK162024 AltiVate Anatomic Shoulder SystemEncore Medical L.P. · 2016 · Recalled
  14. This deviceK173073 AltiVate Anatomic to Reverse Conversion ModuleEncore Medical L.P. · 2017

Most influential descendants

Showing 3 of 3 · See all
  • K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A. · 2022 · cites it directly2descendants
  • K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A. · 2024 · 2 generations on1descendant
  • K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P. · 2025 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−13K911686Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc.1991—
−12K984541Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc.1999—
−11K992065Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage…DePuy Orthopaedics, Inc.1999—
−10K021478Delta ShoulderDepuy, Inc.2003—
−9K030941Aequalis Reversed Shoulder ProsthesisTornier2004—
−8K041873Aequalis Reversed Shoulder ProsthesisTornier2004—
−7K050316Aequalis Reversed Shoulder ProsthesisTornier2005—
−6K061439Aequalis Reversed ProsthesisTornier2006—
−5K071948Aequalis Reversed AdapterTornier2007—
−4K082120Aequalis Reversed Fracture Shoulder ProthesisTornier2008—
−3K103208Reverse Shoulder Prosthesis Monoblock StemEncore Medical L.P.2011—
−2K140904RSP Monoblock Stem with P2 Coating, Size 6Encore Medical L.P.2014—
−1K162024AltiVate Anatomic Shoulder SystemEncore Medical L.P.20166
0 (this device)K173073AltiVate Anatomic to Reverse Conversion ModuleEncore Medical L.P.2017—
+1K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A.20222
+2K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.2024—
+2K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System…Encore Medical L.P.2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198020
198110
198610
198730
198910
199250
199330
199430
199560
199640
199710
199870
199940
200070
200160
200220
200380
200440
200560
200670
200740
200830
200910
201020
201130
201220
201320

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202210
202410
202510
FIG. 1 — Lineage of K173073, 1991–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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 PHX? 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. #1 K212737 INHANCE™ Reverse Shoulder Systemscore 28.4 · 15 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (4)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K162024AltiVate Anatomic Shoulder System
Summary page 4
…noid baseplate is intended for cementless application with the addition of screws for fixation. Predicate Devices: • DJO Surgical AltiVate™ Anatomic Shoulder System – K162024 • DJO Surgical Reverse® Shoulder Prosthesis - K041066 • DJO Surgical Turon to RSP Conversion Shell - K111629 • DJO Surgical…
Encore Medical L.P.20166
*K041066Encore Reverse Shoulder Prosthesis
Summary page 4
…emove a well fixed humeral stem. Compatible Components Component 510(k) Clearance RSP Socket Inserts K041066, K051075, K141006 RSP Glenoid Heads K041066, K051075 RSP Glenoid Baseplate K041066, K…
Encore Medical L.P.20054
*K111629Turon RSP Socket Shell-Neutral Model 508-02-000, Turon RSP Socket Shell-Offset Model…
Summary page 4
…s: • DJO Surgical AltiVate™ Anatomic Shoulder System – K162024 • DJO Surgical Reverse® Shoulder Prosthesis - K041066 • DJO Surgical Turon to RSP Conversion Shell - K111629 • DJO Surgical RSP Size 44 Heads – K092873 Comparable Features to Predicate Device(s): Features comparable to predicate device…
Encore Medical L.P.2011—
*K092873Reverse Shoulder Prosthesis
Summary page 4
…er System – K162024 • DJO Surgical Reverse® Shoulder Prosthesis - K041066 • DJO Surgical Turon to RSP Conversion Shell - K111629 • DJO Surgical RSP Size 44 Heads – K092873 Comparable Features to Predicate Device(s): Features comparable to predicate devices include the same design features, geometry,…
Djo Surgical2009—

Also cleared against K162024: 7 other devices →

What descends from it? (3)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A.20222

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 26 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
  • 30 of the 112 ancestors have a recall of any class.
  • Of its descendants, K212800 (Lima Corporate S.P.A., 2022) has gone furthest, with 2 descendants of its own.
  • 7 other devices also cite its predicate K162024.

How does its category compare?

All PHX devices

PHX Shoulder Prosthesis, Reverse Configuration: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.

FDA decisions per year · PHX

9in 2025

2007: 52008: 62009: 12010: 82011: 122012: 122013: 82014: 122015: 42016: 42017: 112018: 142019: 92020: 132021: 212022: 92023: 92024: 92025: 92026 (partial year): 18
2007high 21 (2021) · low 1 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PHX

72in 2025

2007: 97 days median2008: 79 days median2010: 124 days median2011: 94 days median2012: 114 days median2013: 143 days median2014: 110 days median2015: 206 days median2016: 132 days median2017: 141 days median2018: 127 days median2019: 144 days median2020: 143 days median2021: 143 days median2022: 198 days median2023: 154 days median2024: 139 days median2025: 72 days median2026 (partial year): 130 days median
2007high 206 (2015) · low 72 (2025)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · PHX

3in 2025

2015: 22018: 12019: 32020: 32021: 82023: 72024: 12025: 32026 (partial year): 7
2007high 8 (2021) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · PHX

2,848in 2025

2015: 142016: 52017: 252018: 3232019: 5042020: 9862021: 1,4042022: 1,3422023: 1,4012024: 2,1422025: 2,848
2007high 2,848 (2025) · low 0 (2007)2025

MAUDE reports naming product code PHX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200759700
200867900
20091—00
2010812400
2011129400
20121211400
2013814300
20141211000
20154206214
2016413205
201711141025
2018141271323
201991443504
2020131433986
20212114381,404
2022919801,342
2023915471,401
2024913912,142
202597232,848
2026181307—

What is it indicated for?

The AltiVate Anatomic™ to Reverse Conversion Module is indicated for revision surgeries in patients with a grossly rotator cuff deficient shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly rotator cuff deficient shoulder joint. The patient’s joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. The conversion module…

Read the full statement (110 words)

The AltiVate Anatomic™ to Reverse Conversion Module is indicated for revision surgeries in patients with a grossly rotator cuff deficient shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly rotator cuff deficient shoulder joint. The patient’s joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. The conversion module is only indicated for use with a well fixed AltiVate Anatomic Humeral Stem.

Humeral components with a porous coated surface are indicated for either cemented or uncemented applications. The glenoid baseplate is intended for cementless application with the addition of screws for fixation.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Cite this page

510(k) Report. “K173073: AltiVate Anatomic to Reverse Conversion Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K173073

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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