510(k) · Cleared
Recalled · Class II · 2020Recovery Protrusio Cage
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Cleared on Aug 7, 1997 as substantially equivalent to K953578 (Intermedics Orthopedics, 1995) and 3 other predicates after a 77-day review. Its family tree reaches back 2 generations to 1995. 2 later devices descend from it. It has been recalled once.
- Decided
- Aug 7, 1997
- Review
- 77 days
- Class
- Class II
- Product code
- JDI
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 2 generations to K953578 (1995). 4 ancestors in all, the oldest K943549 (1994). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK953578 Protek Acetabular Roof Reinforcement RingIntermedics Orthopedics · 1995
- 1 generation backK960678 Burch/Schneider Reinforcement CageIntermedics Orthopedics · 1996
- This deviceK971890 Recovery Protrusio CageBiomet, Inc. · 1997
- Descendant · cites it directly · 1 of its ownK990032 Modular Protusio CupBiomet, Inc. · 1999 · Recalled
- Descendant · cites it directly · 0 of its ownK992359 MRS-TitanRotec Medizintechnik GmbH · 2000
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K953578 | Protek Acetabular Roof Reinforcement Ring | Intermedics Orthopedics | 1995 | — |
| −1 | K960678 | Burch/Schneider Reinforcement Cage | Intermedics Orthopedics | 1996 | — |
| 0 (this device) | K971890 | Recovery Protrusio Cage | Biomet, Inc. | 1997 | — |
| +1 | K990032 | Modular Protusio Cup | Biomet, Inc. | 1999 | 1 |
| +1 | K992359 | MRS-Titan | Rotec Medizintechnik GmbH | 2000 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 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.
Planning a device in JDI? 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 JDI device
- #1 K253515 Zimmer Biomet OSS™ Orthopedic Salvage System…score 15.2 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K953578 | Protek Acetabular Roof Reinforcement RingSummary page 2…on. Previously 510(k) cleared competitive acetabular components include: Protek® Acetabular Roof Reinforcement Ring (Intermedics Orthopedics, Inc., Austin, TX) - 510(k) K953578 Bursch/Schneider Reinforcement Cage (Intermedics Orthopedics, Inc., Austin, TX) - 510(k) K960678 Protrusion Cages (Depuy, Warsa… | 1995 |
| * | K960678 | Burch/Schneider Reinforcement CageSummary page 2…Reinforcement Ring (Intermedics Orthopedics, Inc., Austin, TX) - 510(k) K953578 Bursch/Schneider Reinforcement Cage (Intermedics Orthopedics, Inc., Austin, TX) - 510(k) K960678 Protrusion Cages (Depuy, Warsaw, IN) - 510(k) K962007 Restoration™ GAP Acetabular Cup (Osteonics, Allendale, NJ) - 510(k) K94354… | 1996 |
| * | K962007 | Protrusion CagesSummary page 2…in, TX) - 510(k) K953578 Bursch/Schneider Reinforcement Cage (Intermedics Orthopedics, Inc., Austin, TX) - 510(k) K960678 Protrusion Cages (Depuy, Warsaw, IN) - 510(k) K962007 Restoration™ GAP Acetabular Cup (Osteonics, Allendale, NJ) - 510(k) K943549 nCcNoso L SERVIC, S £5.q, Ra 1 C DE… | 1996 |
| * | K943549 | Restoration Acetabular CupSummary page 2…rthopedics, Inc., Austin, TX) - 510(k) K960678 Protrusion Cages (Depuy, Warsaw, IN) - 510(k) K962007 Restoration™ GAP Acetabular Cup (Osteonics, Allendale, NJ) - 510(k) K943549 nCcNoso L SERVIC, S £5.q, Ra 1 C DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service 4 REALTY &° 44,… | 1994 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 25, 2020 | Class II | Z-0627-2021 | Process control | Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 2 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K990032 (Biomet, Inc., 1999) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K953578.
How does its category compare?
All JDI devicesJDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JDI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JDI
59in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JDI
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDI
1,644in 2025
MAUDE reports naming product code JDI, 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 | 3 | 81 | 26 | 696 |
| 2008 | 5 | 96 | 6 | 810 |
| 2009 | 3 | 65 | 3 | 964 |
| 2010 | 0 | — | 3 | 2,040 |
| 2011 | 2 | — | 5 | 3,160 |
| 2012 | 4 | 167 | 4 | 5,122 |
| 2013 | 3 | 176 | 11 | 5,206 |
| 2014 | 3 | 98 | 3 | 4,968 |
| 2015 | 3 | 190 | 1 | 4,906 |
| 2016 | 4 | 166 | 5 | 3,995 |
| 2017 | 1 | — | 5 | 6,135 |
| 2018 | 1 | — | 1 | 6,728 |
| 2019 | 2 | — | 1 | 7,407 |
| 2020 | 7 | 247 | 77 | 4,015 |
| 2021 | 3 | 162 | 0 | 3,170 |
| 2022 | 3 | 69 | 0 | 1,978 |
| 2023 | 2 | — | 0 | 1,635 |
| 2024 | 3 | 59 | 0 | 1,821 |
| 2025 | 1 | — | 1 | 1,644 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Recovery Protrusio Cage is intended for use in reconstruction of the hip joint due to disease, deformity of trauma. The device is intended for cemented application for general use in skeletally mature individuals undergoing primary or secondary revision surgery. The device is a single use implant. The device is to be used in conjunction with any commercially available polyethylene acetabular cup.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971890 · printed Nov 5, 2026
Cite this page
510(k) Report. “K971890: Recovery Protrusio Cage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K971890
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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