510(k) · Cleared
ClearedApr -T Revision Hip Stem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sulzer Orthopedics, Inc. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on May 22, 1998 after a 50-day review. The FDA summary names its predicate without a number. 9 later devices descend from it.
- Decided
- May 22, 1998
- Review
- 50 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 1 citing it directly.
- This deviceK981211 Apr -T Revision Hip StemSulzer Orthopedics, Inc. · 1998
- Descendant · cites it directly · 8 of its ownK112897 Renovis Surgical Hip Joint Replacement ProsthesisRenovis Surgical Technologies, LLC · 2012
- Descendant · 2 generations on · 6 of its ownK132312 Renovis Tesera Trabecular Technology (T3) Acetabular Shell SystemRenovis Surgical Technologies, LLC · 2014
- Descendant · 2 generations on · 4 of its ownK141676 Renovis Surgical Porous Acetabular Cup SystemRenovis Surgical Technologies, Inc. · 2014
- Descendant · 3 generations on · 1 of its ownK200328 Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous…Kyocera Medical Technologies, Inc. · 2020
- Descendant · 2 generations on · 1 of its ownK143647 Renovis Surgical Hip Replacement SystemRenovis Surgical Technologies, Inc. · 2015
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K112897Renovis Surgical Hip Joint Replacement ProsthesisRenovis Surgical Technologies, LLC · 2012 · cites it directly8descendants
- K132312Renovis Tesera Trabecular Technology (T3) Acetabular Shell SystemRenovis Surgical Technologies, LLC · 2014 · 2 generations on6descendants
- K141676Renovis Surgical Porous Acetabular Cup SystemRenovis Surgical Technologies, Inc. · 2014 · 2 generations on4descendants
- K200328Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup SystemKyocera Medical Technologies, Inc. · 2020 · 3 generations on1descendant
- K143647Renovis Surgical Hip Replacement SystemRenovis Surgical Technologies, Inc. · 2015 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K981211 | Apr -T Revision Hip Stem | Sulzer Orthopedics, Inc. | 1998 | — |
| +1 | K112897 | Renovis Surgical Hip Joint Replacement Prosthesis | Renovis Surgical Technologies, LLC | 2012 | — |
| +2 | K132312 | Renovis Tesera Trabecular Technology (T3) Acetabular Shell System | Renovis Surgical Technologies, LLC | 2014 | — |
| +2 | K141676 | Renovis Surgical Porous Acetabular Cup System | Renovis Surgical Technologies, Inc. | 2014 | — |
| +3 | K200328 | Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular… | Kyocera Medical Technologies, Inc. | 2020 | — |
| +2 | K143647 | Renovis Surgical Hip Replacement System | Renovis Surgical Technologies, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2025 | 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 LPH? 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 LPH device
- #1 K233498 Stryker Orthopaedics Hip Systems Labeling Updatescore 24.2 · 20 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | — | APR® Collared Revision Stem Named without a submission number | |
| * | — | APR® Porous Hip Stem Named without a submission number | |
| * | — | BIAS™ Total Hip Prosthesis Named without a submission number | |
| * | — | PCA™ Long Stem Named without a submission number | |
| * | — | Natural-Hip™ Porous Stem Named without a submission number |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112897 | Renovis Surgical Hip Joint Replacement Prosthesis | 2012 | 8 |
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?
- Of its descendants, K112897 (Renovis Surgical Technologies, LLC, 2012) has gone furthest, with 8 descendants of its own.
How does its category compare?
All LPH devicesLPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LPH
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LPH
153in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LPH
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LPH
6,163in 2025
MAUDE reports naming product code LPH, 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 | 10 | 116 | 16 | 509 |
| 2008 | 10 | 86 | 1 | 706 |
| 2009 | 3 | 112 | 2 | 1,156 |
| 2010 | 15 | 100 | 22 | 2,007 |
| 2011 | 16 | 110 | 26 | 3,320 |
| 2012 | 25 | 76 | 30 | 3,785 |
| 2013 | 11 | 135 | 9 | 5,002 |
| 2014 | 20 | 129 | 3 | 5,163 |
| 2015 | 18 | 111 | 1 | 5,830 |
| 2016 | 10 | 150 | 8 | 4,900 |
| 2017 | 12 | 121 | 14 | 5,312 |
| 2018 | 9 | 145 | 2 | 5,954 |
| 2019 | 22 | 164 | 8 | 7,130 |
| 2020 | 7 | 164 | 6 | 5,429 |
| 2021 | 8 | 410 | 4 | 5,978 |
| 2022 | 14 | 247 | 2 | 5,223 |
| 2023 | 10 | 111 | 2 | 5,345 |
| 2024 | 6 | 92 | 1 | 5,626 |
| 2025 | 12 | 153 | 4 | 6,163 |
| 2026 | 8 | 256 | 2 | — |
What is it indicated for?
The APR-T Revision Hip Stem is intended for prosthetic replacement of the proximal portion of the femur during hip arthroplasty. This hip stem can be used for total hip replacements (i.e., replacements where both the femur and acetabulum are replaced) or for hemi-arthroplasties where the hip stem-head assembly articulates directly with well-preserved articular cartilage. For this indication, the stem must be paired with one of the following Sulzcr…
Read the full statement (169 words)
The APR-T Revision Hip Stem is intended for prosthetic replacement of the proximal portion of the femur during hip arthroplasty. This hip stem can be used for total hip replacements (i.e., replacements where both the femur and acetabulum are replaced) or for hemi-arthroplasties where the hip stem-head assembly articulates directly with well-preserved articular cartilage. For this indication, the stem must be paired with one of the following Sulzcr Orthopedics endoprosthesis:
e the Unipolar with 12/14 Taper, cleared for use via 510(k)s K833403 and K934159, or
e the Bipolar component which was cleared for use via 510(k)s K833404 and K873815 and is indicated for use with a CoCr modular femoral head.
Specific diagnostic indications include:
1. Patient conditions of inflammatory degenerative joint disease (e.g., rheumatoid arthritis) and noninflammatory degenerative joint disease (e.g., osteoarthritis, avascular necrosis);
2. Those patients with failed previous surgery where pain, deformity, or dysfunction persist; and,
3. Revision of previously failed hip arthroplasty.
The APR-T Revision Hip Stem is iniended for use with or without bone cement.
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/K981211 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981211: Apr -T Revision Hip Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981211
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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